{
"NDC": [
{
"NDCCode": "53877-008-81",
"PackageDescription": "18 BAG in 1 CASE (53877-008-81) > 1 KIT in 1 BAG * 63 mL in 1 BAG * 100 mL in 1 BAG",
"NDC11Code": "53877-0008-81",
"ProductNDC": "53877-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teruflex Blood Bag System With Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative",
"NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative",
"DosageFormName": "KIT",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20100505",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "BN880217",
"LabelerName": "Terumo Corporation",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20100505",
"SamplePackage": "N",
"IndicationAndUsage": "Issued 6/03 TERUFLEX® BLOOD BAG SYSTEM With DIVERSION BLOOD SAMPLING ARM® CPD/OPTISOL® SOLUTIONRead these instructions carefully before use. Rx ONLY.The Diversion Blood Sampling Arm is intended to divert and collect blood for obtaining donor test samples. For single use only. Sterile and non-pyrogenic fluid path. Sterilized by steam. Intended for the collection, processing and preservation of human blood and components.PRECAUTIONS Do not use unless the solutions are clear. Avoid excessive heat and direct sunlight. Protect from freezing. Recommended storage conditions: Room Temperature (15-30°C/59-86°F). The blood bag configuration is specified on the blister pack label.CAUTION Do not use a dielectric tube sealer to seal the tubing while the needle is connected to the donor's body unless it is approved for such a purpose.INSTRUCTIONS FOR BLOOD COLLECTION: Use aseptic techniqueMaterials Needed: VENOJECT® ll Tube Holder (code P-1316R) or equivalentVENOJECT® ll Multi-Sample Luer Adapter (code MN *2000T) or equivalentEvacuated Blood Collection Tubes (glass or plastic)1. Prepare the blood bag following your institution's standard operating procedures.2. If applicable, make a loose knot in the donor tubing below the \"Y\" and CLIKTIP (inline closure device) unless alternate methods are used to seal the tubing at the end of collection.3. Temporarily clamp the donor tubing between the phlebotomy needle and the \"Y\".4. Close the White Clamp below the diversion pouch.5. Tube Holder/Luer Adapter Assembly:a) Connect the VENOJECT II Multi-Sample Luer Adapter to the VENOJECT II Tube Holder (or equivalent) (Fig.1).Insert Fig. 1 here. b) Twist and snap to remove the blue port cap at the end of the Diversion Blood sampling Arm (Fig. 2a).c) Connect the multi-sample luer adapter to the female luer port. (Fig. 2b)NOTE: Alternatively, steps a, b and c (above) may be performed at any time during bag preparation or after the blood is collected into the diversion pouch.Insert Fig. 2a and 2b here. 6. Suspend the collection bag as far as possible below the donor's arm.7. Apply blood pressure cuff or tourniquet to donor's arm. Disinfect site of phlebotomy. If blood pressure cuff is used, inflate to approximately 60 mmHg.8. Remove the needle cover and perform phlebotomy. Remove the temporary clamp on the donor tubing to permit blood flow into the Diversion Blood Sampling Arm pouch.CAUTION Do not touch the needle after removing the needle protector. Assure that the White Clamp below the pouch is closed prior to initiating phlebotomy.9. If using a needle safety device, follow the manufacturer's instructions to secure the device in place.10. Appropriately secure donor tubing to donor's arm.11. Position the diversion pouch with the notches up and the Tube Holder/Luer Adapter assembly (or port cap) down. When the level of blood in the pouch is approximately in linewith the notches, the diversion pouch is full. (Fig. 3a)NOTE: The approximate fill volume of the pouch at the notches is 35 mL.12. Permanently seal the tubing between the \"Y\" and the diversion pouch to maintain a closed system using an aluminum clip or a tube sealer approved for use with tubing connected to a donor. (Fig. 3b)13. To initiate blood flow into the collection bag, break the CLlKTIP between the \"Y\" and the primary bag.14. To avoid clot formation, collect samples as soon as possible from the diversion pouch as follows (Fig. 3b)CAUTION Do not collect donor test samples until the tubing between the \"Y\" and the diversion pouch is permanently sealed.a) Open the White Clamp on the tubing below the pouch to open the pathway for sampling.b) Position the diversion pouch with the notches up and the Tube Holder/Luer Adapter assembly down. Assure that any air in the pouch is at the top and will not enter theblood collection tubes.c) Insert vacuum blood collection tube firmly into the tube holder; when full, remove sample tube from holder. Repeat to collect additional samples.NOTE: The pouch may be removed after the donor test samples are collected. A second seal must be made between the diversion pouch and the permanent sealprior to removing the pouch.Insert Fig. 3a and 3b here. 15. Once samples are obtained, mix blood with anticoagulant in the primary bag and continue to mix at several intervals during collection. 16. Collect labeled volume of blood (+/–10%).17. When the desired amount of blood has been collected, seal the tubing or tighten the loose knot (white knot) prepared in step 2. Make a second seal between the first seal or knot andthe CLlKTIP below the \"Y\". Various methods may be used to seal tubing.18. Release pressure on the donor's arm and remove the needle. If using a needle safety device, follow the manufacturer's instructions to remove the needle. Sever the donor tubing between the two seals previously made below the CLlKTIP and \"Y\".CAUTION Discard the Diversion Blood Sampling Arm and phlebotomy needle/donor tubing according to institutional procedures.19. Immediately after collection, invert the bag several times to assure blood and anticoagulant are well mixed.20. Strip blood from the donor tubing into the bag, mix well, and allow tubing to refill. Seal on or near the X marks on the donor tubing to provide numbered aliquots of anticoagulated blood for testing.21. The time of addition of OPTISOL Solution may vary depending on the processing option selected. Add the solution under one of the following conditions after removal of plasma:a) Within 8 hours of whole blood collection, if components are prepared.b) Within 72 hours of collection if whole blood is refrigerated immediately following collection.22. Centrifuge the unit to separate red cells from plasma.23. Break the CLlKTIP of primary collection bag and transfer the plasma into the satellite bag. Clamp transfer tubing of satellite bag.24. Break the CLlKTIP of OPTlSOL Solution bag and drain contents into primary bag containing red blood cells. Seal tubing of primary bag in two places, and cut between sealsand separate from satellite bag(s).NOTE: For TERUFLEX double bags, seal OPTISOL Solution bag tubing in two places and cut between seals. Discard OPTISOL Solution container.25. Invert the red cell- OPTISOL mixture several times to insure the final AS-5 red cell product is well suspended.26. Store AS-5 Red Blood Cells between 1-6°C.27. Infuse AS-5 Red Blood Cells within 42 days of collection.For further processing, use standard component processing techniques.To open blister package, peel cover film back four fifths of its length. After opening, unused bags may be stored for 30 days by returning cover film to original position and sealing with tape to prevent possible loss of moisture.Insert Fig. 4 here. CAUTIONSThe packet of AGELESS contained in this package absorbs oxygen and generates heat on removal. Handle it with care. Dispose with packet in tray. Do not dispose with wastes containing volatile or flammable materials. Discard AGELESS packet without opening.N-BB-OP-A2(DB) 1TERUMO® MANUFACTURED BY: TERUMO CORPORATION 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO, JAPAN MADE IN JAPAN®: Registered Trademark Diversion Blood Sampling Arm and CLIKTIP are trademarks of TERUMO CORPORATION.© TERUMO CORPORATION 2003 03F10."
},
{
"NDCCode": "53877-008-51",
"PackageDescription": "24 BAG in 1 CASE (53877-008-51) > 1 KIT in 1 BAG * 63 mL in 1 BAG * 100 mL in 1 BAG",
"NDC11Code": "53877-0008-51",
"ProductNDC": "53877-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teruflex Blood Bag System With Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative",
"NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative",
"DosageFormName": "KIT",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20100505",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "BN880217",
"LabelerName": "Terumo Corporation",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20100505",
"SamplePackage": "N",
"IndicationAndUsage": "Issued 6/03 TERUFLEX® BLOOD BAG SYSTEM With DIVERSION BLOOD SAMPLING ARM® CPD/OPTISOL® SOLUTIONRead these instructions carefully before use. Rx ONLY.The Diversion Blood Sampling Arm is intended to divert and collect blood for obtaining donor test samples. For single use only. Sterile and non-pyrogenic fluid path. Sterilized by steam. Intended for the collection, processing and preservation of human blood and components.PRECAUTIONS Do not use unless the solutions are clear. Avoid excessive heat and direct sunlight. Protect from freezing. Recommended storage conditions: Room Temperature (15-30°C/59-86°F). The blood bag configuration is specified on the blister pack label.CAUTION Do not use a dielectric tube sealer to seal the tubing while the needle is connected to the donor's body unless it is approved for such a purpose.INSTRUCTIONS FOR BLOOD COLLECTION: Use aseptic techniqueMaterials Needed: VENOJECT® ll Tube Holder (code P-1316R) or equivalentVENOJECT® ll Multi-Sample Luer Adapter (code MN *2000T) or equivalentEvacuated Blood Collection Tubes (glass or plastic)1. Prepare the blood bag following your institution's standard operating procedures.2. If applicable, make a loose knot in the donor tubing below the \"Y\" and CLIKTIP (inline closure device) unless alternate methods are used to seal the tubing at the end of collection.3. Temporarily clamp the donor tubing between the phlebotomy needle and the \"Y\".4. Close the White Clamp below the diversion pouch.5. Tube Holder/Luer Adapter Assembly:a) Connect the VENOJECT II Multi-Sample Luer Adapter to the VENOJECT II Tube Holder (or equivalent) (Fig.1).Insert Fig. 1 hereb) Twist and snap to remove the blue port cap at the end of the Diversion Blood sampling Arm (Fig. 2a).c) Connect the multi-sample luer adapter to the female luer port. (Fig. 2b)NOTE: Alternatively, steps a, b and c (above) may be performed at any time during bag preparation or after the blood is collected into the diversion pouch.Insert Fig. 2a and 2b here6. Suspend the collection bag as far as possible below the donor's arm.7. Apply blood pressure cuff or tourniquet to donor's arm. Disinfect site of phlebotomy. If blood pressure cuff is used, inflate to approximately 60 mmHg.8. Remove the needle cover and perform phlebotomy. Remove the temporary clamp on the donor tubing to permit blood flow into the Diversion Blood Sampling Arm pouch.CAUTION Do not touch the needle after removing the needle protector. Assure that the White Clamp below the pouch is closed prior to initiating phlebotomy.9. If using a needle safety device, follow the manufacturer's instructions to secure the device in place.10. Appropriately secure donor tubing to donor's arm.11. Position the diversion pouch with the notches up and the Tube Holder/Luer Adapter assembly (or port cap) down. When the level of blood in the pouch is approximately in linewith the notches, the diversion pouch is full. (Fig. 3a)NOTE: The approximate fill volume of the pouch at the notches is 35 mL.12. Permanently seal the tubing between the \"Y\" and the diversion pouch to maintain a closed system using an aluminum clip or a tube sealer approved for use with tubing connected to a donor. (Fig. 3b)13. To initiate blood flow into the collection bag, break the CLlKTIP between the \"Y\" and the primary bag.14. To avoid clot formation, collect samples as soon as possible from the diversion pouch as follows (Fig. 3b)CAUTION Do not collect donor test samples until the tubing between the \"Y\" and the diversion pouch is permanently sealed.a) Open the White Clamp on the tubing below the pouch to open the pathway for sampling.b) Position the diversion pouch with the notches up and the Tube Holder/Luer Adapter assembly down. Assure that any air in the pouch is at the top and will not enter theblood collection tubes.c) Insert vacuum blood collection tube firmly into the tube holder; when full, remove sample tube from holder. Repeat to collect additional samples.NOTE: The pouch may be removed after the donor test samples are collected. A second seal must be made between the diversion pouch and the permanent sealprior to removing the pouch.Insert Fig. 3a and 3b here15. Once samples are obtained, mix blood with anticoagulant in the primary bag and continue to mix at several intervals during collection. 16. Collect labeled volume of blood (+/–10%).17. When the desired amount of blood has been collected, seal the tubing or tighten the loose knot (white knot) prepared in step 2. Make a second seal between the first seal or knot andthe CLlKTIP below the \"Y\". Various methods may be used to seal tubing.18. Release pressure on the donor's arm and remove the needle. If using a needle safety device, follow the manufacturer's instructions to remove the needle. Sever the donor tubing between the two seals previously made below the CLlKTIP and \"Y\".CAUTION Discard the Diversion Blood Sampling Arm and phlebotomy needle/donor tubing according to institutional procedures.19. Immediately after collection, invert the bag several times to assure blood and anticoagulant are well mixed.20. Strip blood from the donor tubing into the bag, mix well, and allow tubing to refill. Seal on or near the X marks on the donor tubing to provide numbered aliquots of anticoagulated blood for testing.21. The time of addition of OPTISOL Solution may vary depending on the processing option selected. Add the solution under one of the following conditions after removal of plasma:a) Within 8 hours of whole blood collection, if components are prepared.b) Within 72 hours of collection if whole blood is refrigerated immediately following collection.22. Centrifuge the unit to separate red cells from plasma.23. Break the CLlKTIP of primary collection bag and transfer the plasma into the satellite bag. Clamp transfer tubing of satellite bag.24. Break the CLlKTIP of OPTlSOL Solution bag and drain contents into primary bag containing red blood cells. Seal tubing of primary bag in two places, and cut between sealsand separate from satellite bag(s).NOTE: For TERUFLEX double bags, seal OPTISOL Solution bag tubing in two places and cut between seals. Discard OPTISOL Solution container.25. Invert the red cell- OPTISOL mixture several times to insure the final AS-5 red cell product is well suspended.26. Store AS-5 Red Blood Cells between 1-6°C.27. Infuse AS-5 Red Blood Cells within 42 days of collection.For further processing, use standard component processing techniques.To open blister package, peel cover film back four fifths of its length. After opening, unused bags may be stored for 30 days by returning cover film to original position and sealing with tape to prevent possible loss of moisture.Insert Fig. 4 hereCAUTIONSThe packet of AGELESS contained in this package absorbs oxygen and generates heat on removal. Handle it with care. Dispose with packet in tray. Do not dispose with wastes containing volatile or flammable materials. Discard AGELESS packet without opening.N-BB-OP-A2(DB) 1TERUMO® MANUFACTURED BY: TERUMO CORPORATION 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO, JAPAN MADE IN JAPAN®: Registered Trademark Diversion Blood Sampling Arm and CLIKTIP are trademarks of TERUMO CORPORATION.© TERUMO CORPORATION 2003 03F10."
},
{
"NDCCode": "53877-008-61",
"PackageDescription": "24 BAG in 1 CASE (53877-008-61) > 1 KIT in 1 BAG * 70 mL in 1 BAG * 111 mL in 1 BAG",
"NDC11Code": "53877-0008-61",
"ProductNDC": "53877-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teruflex Blood Bag System With Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative",
"NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative",
"DosageFormName": "KIT",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20100505",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "BN880217",
"LabelerName": "Terumo Corporation",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20100505",
"SamplePackage": "N",
"IndicationAndUsage": "Issued 6/03 TERUFLEX® BLOOD BAG SYSTEM With DIVERSION BLOOD SAMPLING ARM® CPD/OPTISOL® SOLUTIONRead these instructions carefully before use. Rx ONLY.The Diversion Blood Sampling Arm is intended to divert and collect blood for obtaining donor test samples. For single use only. Sterile and non-pyrogenic fluid path. Sterilized by steam. Intended for the collection, processing and preservation of human blood and components.PRECAUTIONS Do not use unless the solutions are clear. Avoid excessive heat and direct sunlight. Protect from freezing. Recommended storage conditions: Room Temperature (15-30°C/59-86°F). The blood bag configuration is specified on the blister pack label.CAUTION Do not use a dielectric tube sealer to seal the tubing while the needle is connected to the donor's body unless it is approved for such a purpose.INSTRUCTIONS FOR BLOOD COLLECTION: Use aseptic techniqueMaterials Needed: VENOJECT® ll Tube Holder (code P-1316R) or equivalentVENOJECT® ll Multi-Sample Luer Adapter (code MN *2000T) or equivalentEvacuated Blood Collection Tubes (glass or plastic)1. Prepare the blood bag following your institution's standard operating procedures.2. If applicable, make a loose knot in the donor tubing below the \"Y\" and CLIKTIP (inline closure device) unless alternate methods are used to seal the tubing at the end of collection.3. Temporarily clamp the donor tubing between the phlebotomy needle and the \"Y\".4. Close the White Clamp below the diversion pouch.5. Tube Holder/Luer Adapter Assembly:a) Connect the VENOJECT II Multi-Sample Luer Adapter to the VENOJECT II Tube Holder (or equivalent) (Fig.1).Insert Fig. 1 hereb) Twist and snap to remove the blue port cap at the end of the Diversion Blood sampling Arm (Fig. 2a).c) Connect the multi-sample luer adapter to the female luer port. (Fig. 2b)NOTE: Alternatively, steps a, b and c (above) may be performed at any time during bag preparation or after the blood is collected into the diversion pouch.Insert Fig. 2a and 2b here6. Suspend the collection bag as far as possible below the donor's arm.7. Apply blood pressure cuff or tourniquet to donor's arm. Disinfect site of phlebotomy. If blood pressure cuff is used, inflate to approximately 60 mmHg.8. Remove the needle cover and perform phlebotomy. Remove the temporary clamp on the donor tubing to permit blood flow into the Diversion Blood Sampling Arm pouch.CAUTION Do not touch the needle after removing the needle protector. Assure that the White Clamp below the pouch is closed prior to initiating phlebotomy.9. If using a needle safety device, follow the manufacturer's instructions to secure the device in place.10. Appropriately secure donor tubing to donor's arm.11. Position the diversion pouch with the notches up and the Tube Holder/Luer Adapter assembly (or port cap) down. When the level of blood in the pouch is approximately in linewith the notches, the diversion pouch is full. (Fig. 3a)NOTE: The approximate fill volume of the pouch at the notches is 35 mL.12. Permanently seal the tubing between the \"Y\" and the diversion pouch to maintain a closed system using an aluminum clip or a tube sealer approved for use with tubing connected to a donor. (Fig. 3b)13. To initiate blood flow into the collection bag, break the CLlKTIP between the \"Y\" and the primary bag.14. To avoid clot formation, collect samples as soon as possible from the diversion pouch as follows (Fig. 3b)CAUTION Do not collect donor test samples until the tubing between the \"Y\" and the diversion pouch is permanently sealed.a) Open the White Clamp on the tubing below the pouch to open the pathway for sampling.b) Position the diversion pouch with the notches up and the Tube Holder/Luer Adapter assembly down. Assure that any air in the pouch is at the top and will not enter theblood collection tubes.c) Insert vacuum blood collection tube firmly into the tube holder; when full, remove sample tube from holder. Repeat to collect additional samples.NOTE: The pouch may be removed after the donor test samples are collected. A second seal must be made between the diversion pouch and the permanent sealprior to removing the pouch.Insert Fig. 3a and 3b here. 15. Once samples are obtained, mix blood with anticoagulant in the primary bag and continue to mix at several intervals during collection. 16. Collect labeled volume of blood (+/–10%).17. When the desired amount of blood has been collected, seal the tubing or tighten the loose knot (white knot) prepared in step 2. Make a second seal between the first seal or knot andthe CLlKTIP below the \"Y\". Various methods may be used to seal tubing.18. Release pressure on the donor's arm and remove the needle. If using a needle safety device, follow the manufacturer's instructions to remove the needle. Sever the donor tubing between the two seals previously made below the CLlKTIP and \"Y\".CAUTION Discard the Diversion Blood Sampling Arm and phlebotomy needle/donor tubing according to institutional procedures.19. Immediately after collection, invert the bag several times to assure blood and anticoagulant are well mixed.20. Strip blood from the donor tubing into the bag, mix well, and allow tubing to refill. Seal on or near the X marks on the donor tubing to provide numbered aliquots of anticoagulated blood for testing.21. The time of addition of OPTISOL Solution may vary depending on the processing option selected. Add the solution under one of the following conditions after removal of plasma:a) Within 8 hours of whole blood collection, if components are prepared.b) Within 72 hours of collection if whole blood is refrigerated immediately following collection.22. Centrifuge the unit to separate red cells from plasma.23. Break the CLlKTIP of primary collection bag and transfer the plasma into the satellite bag. Clamp transfer tubing of satellite bag.24. Break the CLlKTIP of OPTlSOL Solution bag and drain contents into primary bag containing red blood cells. Seal tubing of primary bag in two places, and cut between sealsand separate from satellite bag(s).NOTE: For TERUFLEX double bags, seal OPTISOL Solution bag tubing in two places and cut between seals. Discard OPTISOL Solution container.25. Invert the red cell- OPTISOL mixture several times to insure the final AS-5 red cell product is well suspended.26. Store AS-5 Red Blood Cells between 1-6°C.27. Infuse AS-5 Red Blood Cells within 42 days of collection.For further processing, use standard component processing techniques.To open blister package, peel cover film back four fifths of its length. After opening, unused bags may be stored for 30 days by returning cover film to original position and sealing with tape to prevent possible loss of moisture.Insert Fig. 4 here. CAUTIONSThe packet of AGELESS contained in this package absorbs oxygen and generates heat on removal. Handle it with care. Dispose with packet in tray. Do not dispose with wastes containing volatile or flammable materials. Discard AGELESS packet without opening.N-BB-OP-A2(DB) 1TERUMO® MANUFACTURED BY: TERUMO CORPORATION 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO, JAPAN MADE IN JAPAN®: Registered Trademark Diversion Blood Sampling Arm and CLIKTIP are trademarks of TERUMO CORPORATION.© TERUMO CORPORATION 2003 03F10."
},
{
"NDCCode": "53877-008-71",
"PackageDescription": "18 BAG in 1 CASE (53877-008-71) > 1 KIT in 1 BAG * 70 mL in 1 BAG * 111 mL in 1 BAG",
"NDC11Code": "53877-0008-71",
"ProductNDC": "53877-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teruflex Blood Bag System With Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative",
"NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative",
"DosageFormName": "KIT",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20100505",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "BN880217",
"LabelerName": "Terumo Corporation",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20100505",
"SamplePackage": "N",
"IndicationAndUsage": "1.1. Read these instructions carefully before use. 1.2. Rx ONLY. 1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion. 1.4. For the collection of 450 mL ±10% or 500 mL ±10% Whole Blood. 1.5. Integral Diversion Blood Sampling Arm is intended to divert and obtain donor samples for laboratory testing prior to collection of the Whole Blood unit. 1.6. For further processing, use standard component processing techniques.",
"Description": "11.1. This blood bag system includes a 16 gauge × 1 1/2 inch (1.60 × 38 mm) needle with needle cover and either a 450mL or 500mL (nominal capacity 600mL) primary collection bag containing 63 mL or 70mL, respectively, Citrate Phosphate Dextrose (CPD) anticoagulant. The Double blood bag set has one integrally attached empty satellite bag and one satellite bag containing 100 mL or 111 mL, respectively, OPTISOL Red Cell Preservative Solution. The Triple blood bag set has one empty XT-612 5 day Platelet bag and one satellite bag containing 100 mL or 111 mL, respectively, OPTISOL Red Cell Preservative Solution. The Quadruple blood bag set has one integrally attached empty XT-612 5 day Platelet bag, one empty satellite bag, and one satellite bag containing 100 mL or 111 mL, respectively, OPTISOL Red Cell Preservative Solution. 11.2. Blood bag codes ending in A2 are supplied with Integral Diversion Blood Sampling Arm intended to divert and obtain donor samples for laboratory testing prior to collection of the Whole Blood unit. 11.3. Blood bag codes ending in A2 also include a DonorCare® Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4. The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5. The blood bag has no components made of natural rubber latex. 11.6. Tubing internal diameter (ID) nominal 3.0 mm. 11.7. Tubing outer diameter (OD) nominal 4.4 mm. 11.8. Donor tubing line maximum 16 segments available."
},
{
"NDCCode": "12022-008-00",
"PackageDescription": "1 BOTTLE in 1 CARTON (12022-008-00) / 81 mL in 1 BOTTLE",
"NDC11Code": "12022-0008-00",
"ProductNDC": "12022-008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Glovers Dandruff Control Med., Floral",
"NonProprietaryName": "Sulfur",
"DosageFormName": "SUSPENSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20011105",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "J. Strickland & Co.",
"SubstanceName": "SULFUR",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2023-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20011105",
"SamplePackage": "N",
"IndicationAndUsage": "Controls scalp itching and flaking due to dandruff."
},
{
"NDCCode": "50814-008-01",
"PackageDescription": ".81 mL in 1 BAG (50814-008-01) ",
"NDC11Code": "50814-0008-01",
"ProductNDC": "50814-008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antiseptic Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160701",
"EndMarketingDate": "20251231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "GFA Production (Xiamen) Co., Ltd.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160701",
"EndMarketingDatePackage": "20251231",
"SamplePackage": "N",
"IndicationAndUsage": "For handwashing to decrease bacteria on the skin. Recommended for repeated use."
},
{
"NDCCode": "77720-008-03",
"PackageDescription": "20 POUCH in 1 BAG (77720-008-03) > 81 g in 1 POUCH",
"NDC11Code": "77720-0008-03",
"ProductNDC": "77720-008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizing Wipes",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200915",
"EndMarketingDate": "20200920",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Skaffles Group Limited Liability Company",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-09-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200915",
"EndMarketingDatePackage": "20200920",
"SamplePackage": "N"
},
{
"NDCCode": "10019-008-01",
"PackageDescription": "1 PATCH in 1 POUCH (10019-008-01) / 3 d in 1 PATCH",
"NDC11Code": "10019-0008-01",
"ProductNDC": "10019-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Transderm Scop",
"NonProprietaryName": "Scopolamine",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20161201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017874",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "SCOPOLAMINE",
"StrengthNumber": "1",
"StrengthUnit": "mg/3d",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20260610",
"SamplePackage": "N",
"IndicationAndUsage": "TRANSDERM SCŌP is indicated in adults for the prevention of: 1 nausea and vomiting associated with motion sickness., 2 post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery.",
"Description": "TRANSDERM SCŌP (scopolamine transdermal system) is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.3 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is. Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The TRANSDERM SCŌPtransdermal system is a circular, 0.2 mm thick, 2.5 cm2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film; (2) a drug layer of scopolamine, crospovidone, isopropyl palmitate, light mineral oil, and polyisobutylene; (3) an ethylene vinyl acetate copolymer membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, and scopolamine. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used. Cross section of the system."
},
{
"NDCCode": "10019-008-04",
"PackageDescription": "4 POUCH in 1 BOX (10019-008-04) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH",
"NDC11Code": "10019-0008-04",
"ProductNDC": "10019-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Transderm Scop",
"NonProprietaryName": "Scopolamine",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20161201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017874",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "SCOPOLAMINE",
"StrengthNumber": "1",
"StrengthUnit": "mg/3d",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250610",
"SamplePackage": "N",
"IndicationAndUsage": "TRANSDERM SCŌP is indicated in adults for the prevention of: 1 nausea and vomiting associated with motion sickness., 2 post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery.",
"Description": "TRANSDERM SCŌP (scopolamine transdermal system) is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.3 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is. Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The TRANSDERM SCŌPtransdermal system is a circular, 0.2 mm thick, 2.5 cm2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film; (2) a drug layer of scopolamine, crospovidone, isopropyl palmitate, light mineral oil, and polyisobutylene; (3) an ethylene vinyl acetate copolymer membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, and scopolamine. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used. Cross section of the system."
},
{
"NDCCode": "10019-008-10",
"PackageDescription": "10 POUCH in 1 BOX (10019-008-10) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH",
"NDC11Code": "10019-0008-10",
"ProductNDC": "10019-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Transderm Scop",
"NonProprietaryName": "Scopolamine",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20161201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017874",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "SCOPOLAMINE",
"StrengthNumber": "1",
"StrengthUnit": "mg/3d",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250610",
"SamplePackage": "N",
"IndicationAndUsage": "TRANSDERM SCŌP is indicated in adults for the prevention of: 1 nausea and vomiting associated with motion sickness., 2 post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery.",
"Description": "TRANSDERM SCŌP (scopolamine transdermal system) is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.3 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is. Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The TRANSDERM SCŌPtransdermal system is a circular, 0.2 mm thick, 2.5 cm2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film; (2) a drug layer of scopolamine, crospovidone, isopropyl palmitate, light mineral oil, and polyisobutylene; (3) an ethylene vinyl acetate copolymer membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, and scopolamine. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used. Cross section of the system."
},
{
"NDCCode": "10019-008-24",
"PackageDescription": "24 POUCH in 1 BOX (10019-008-24) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH",
"NDC11Code": "10019-0008-24",
"ProductNDC": "10019-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Transderm Scop",
"NonProprietaryName": "Scopolamine",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20161201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017874",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "SCOPOLAMINE",
"StrengthNumber": "1",
"StrengthUnit": "mg/3d",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250610",
"SamplePackage": "N",
"IndicationAndUsage": "TRANSDERM SCŌP is indicated in adults for the prevention of: 1 nausea and vomiting associated with motion sickness., 2 post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery.",
"Description": "TRANSDERM SCŌP (scopolamine transdermal system) is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.3 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is. Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The TRANSDERM SCŌPtransdermal system is a circular, 0.2 mm thick, 2.5 cm2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film; (2) a drug layer of scopolamine, crospovidone, isopropyl palmitate, light mineral oil, and polyisobutylene; (3) an ethylene vinyl acetate copolymer membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, and scopolamine. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used. Cross section of the system."
},
{
"NDCCode": "10631-008-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10631-008-30) ",
"NDC11Code": "10631-0008-30",
"ProductNDC": "10631-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kapspargo",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180315",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210428",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-04-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180315",
"SamplePackage": "N",
"IndicationAndUsage": "KAPSPARGO Sprinkle is a beta1-adrenergic blocker indicated for the treatment of: Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) Angina Pectoris. (1.2) Heart Failure, to reduce the risk of cardiovascular mortality and heart-failure hospitalizations in patients with heart failure. (1.3).",
"Description": "Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release capsules. Metoprolol succinate extended-release capsules have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The extended-release capsules comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The extended-release capsules contain 10.24 mg, 20.48 mg, 40.96 mg, and 81.92 mg of metoprolol free base, present as 23.75 mg, 47.5 mg, 95 mg, and 190 mg of metoprolol succinate and are equivalent to 25 mg, 50 mg, 100 mg, and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate, USP is a white to off-white powder with a molecular weight of 652.82. It is freely soluble in water, soluble in methanol, sparingly soluble in alcohol, slightly soluble in isopropyl alcohol. Inactive ingredients: ethyl cellulose, hypromellose, polyethylene glycol 400, polyethylene glycol 6000, sugar spheres (corn starch and sucrose), talc and triethyl citrate. The capsule shell and imprinting ink has the following composition: ferric oxide yellow (25 mg, 50 mg and 200 mg), ferrosoferric oxide, gelatin, potassium hydroxide, propylene glycol, shellac and titanium dioxide."
},
{
"NDCCode": "63304-008-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-008-30) ",
"NDC11Code": "63304-0008-30",
"ProductNDC": "63304-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180207",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210428",
"LabelerName": "Sun Pharmaceutical Industries Inc.",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2018-02-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180207",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol succinate extended-release capsules are beta1-selective adrenoceptor blocking agent indicated for the treatment of: : 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) , 2 Angina Pectoris. (1.2) , 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart-failure hospitalization in patients with heart failure. (1.3).",
"Description": "Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release capsules. Metoprolol succinate extended-release capsules have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The extended-release capsules comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The extended-release capsules contain 10.24 mg, 20.48 mg, 40.96 mg, and 81.92 mg of metoprolol free base, present as 23.75 mg, 47.5 mg, 95 mg, and 190 mg of metoprolol succinate and are equivalent to 25 mg, 50 mg, 100 mg, and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate, USP is a white to off-white powder with a molecular weight of 652.82. It is freely soluble in water, soluble in methanol, sparingly soluble in alcohol, slightly soluble in isopropyl alcohol. Inactive ingredients: ethyl cellulose, hypromellose, polyethylene glycol 400, polyethylene glycol 6000, sugar spheres (corn starch and sucrose), talc and triethyl citrate. The capsule shell and imprinting ink has the following composition: ferric oxide yellow (25 mg, 50 mg and 200 mg), ferrosoferric oxide, gelatin, potassium hydroxide, propylene glycol, shellac and titanium dioxide."
},
{
"NDCCode": "71635-090-02",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (71635-090-02) > 81 g in 1 BOTTLE, PLASTIC (71635-090-01)",
"NDC11Code": "71635-0090-02",
"ProductNDC": "71635-090",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mulbit",
"ProprietaryNameSuffix": "Medist",
"NonProprietaryName": "Niacinamide, Adenosine",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171001",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "First Cosmetic Co., Ltd",
"SubstanceName": "NIACINAMIDE; ADENOSINE",
"StrengthNumber": ".08; .008",
"StrengthUnit": "g/81g; g/81g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Uses: MULBIT MEDIST is a tablet that contains fruit ingredients of lemon and strawberry and vitamin C, B2 and B3. The carbonic bubbles created while the tablet is being dissolved in water eliminate wastes from your skin, stimulating the skin and they cleanse and brighten your skin. The fruit ingredients of lemon and strawberry and other ingredients such as vitamin, sucrose, trehalose and adenosine supply nutrients to your skin and moisturize, creating a thin moisturizing coat which makes your skin even moister."
},
{
"NDCCode": "53877-001-01",
"PackageDescription": "30 BAG in 1 CASE (53877-001-01) > 35 mL in 1 BAG",
"NDC11Code": "53877-0001-01",
"ProductNDC": "53877-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
"NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20091118",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "BN820528",
"LabelerName": "Terumo Corporation",
"SubstanceName": "ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
"StrengthNumber": ".275; 2.99; 31.9; 2.22; 26.3",
"StrengthUnit": "g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL",
"Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20091118",
"SamplePackage": "N",
"IndicationAndUsage": "For the collection of 250 mL of Whole Blood. Revised 2015-12 N-BB-A 3. FULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 7, 8, 9, 10, 12, 13, 14, 15 and 17].1. INDICATIONS AND USAGE1.1. Read these instructions carefully before use. 1.2. Rx ONLY.1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4. For the collection of 250 mL ±10% Whole Blood: 1.4.1. From elderly, pediatric, or smaller autologous donors who may not tolerate larger blood collections. 1.4.2. For blood collections as directed by a patient's physician.1.5. NOTE: Production of Platelets and Plasma is not intended with this product.",
"Description": "11. DESCRIPTION. 11.1. This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and a 250 mL (nominal capacity 300 mL) collection bag containing 35 mL Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant. 11.2. The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.3. The blood bag has no components made of natural rubber latex. 11.4. Tubing internal diameter (ID) nominal 3.0 mm. 11.5. Tubing outer diameter (OD) nominal 4.4 mm. 11.6. Donor tubing line maximum 12 segments available."
},
{
"NDCCode": "53877-001-02",
"PackageDescription": "30 BAG in 1 CASE (53877-001-02) > 63 mL in 1 BAG",
"NDC11Code": "53877-0001-02",
"ProductNDC": "53877-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
"NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20091210",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "BN820528",
"LabelerName": "Terumo Corporation",
"SubstanceName": "ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
"StrengthNumber": ".275; 2.99; 31.9; 2.22; 26.3",
"StrengthUnit": "g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL",
"Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20091210",
"SamplePackage": "N",
"IndicationAndUsage": "Revised 2011-11 N-BB-CA-A 5BB89X505+5FULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 7, 8, 9, 10, 12, 13, 14, 15 and 17].1. INDICATIONS AND USAGE1.1. Read these instructions carefully before use.1.2. Rx ONLY1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4. For the collection of 450 mL +/- 10% Whole Blood.1.5. For further processing, use standard component processing techniques.",
"Description": "11. DESCRIPTION. 11.1. This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and a 450 mL (nominal capacity 600 mL) primary collection bag containing 63 mL Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant. The Double blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL). The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2. The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.3. The blood bag has no components made of natural rubber latex. 11.4. Tubing internal diameter (ID) nominal 3.0 mm. 11.5. Tubing outer diameter (OD) nominal 4.4 mm. 11.6. Donor tubing line maximum 19 segments available."
},
{
"NDCCode": "53877-001-03",
"PackageDescription": "60 BAG in 1 CASE (53877-001-03) > 63 mL in 1 BAG",
"NDC11Code": "53877-0001-03",
"ProductNDC": "53877-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
"NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20091210",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "BN820528",
"LabelerName": "Terumo Corporation",
"SubstanceName": "ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
"StrengthNumber": ".275; 2.99; 31.9; 2.22; 26.3",
"StrengthUnit": "g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL",
"Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20091210",
"SamplePackage": "N",
"IndicationAndUsage": "Revised 2011-11 N-BB-CA-A 5BB89X505+5FULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 7, 8, 9, 10, 12, 13, 14, 15 and 17].1. INDICATIONS AND USAGE1.1. Read these instructions carefully before use.1.2. Rx ONLY1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4. For the collection of 450 mL +/- 10% Whole Blood.1.5. For further processing, use standard component processing techniques.",
"Description": "11. DESCRIPTION. 11.1. This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and a 450 mL (nominal capacity 600 mL) primary collection bag containing 63 mL Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant. The Double blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL). The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2. The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.3. The blood bag has no components made of natural rubber latex. 11.4. Tubing internal diameter (ID) nominal 3.0 mm. 11.5. Tubing outer diameter (OD) nominal 4.4 mm. 11.6. Donor tubing line maximum 19 segments available."
},
{
"NDCCode": "53877-001-04",
"PackageDescription": "48 BAG in 1 CASE (53877-001-04) > 63 mL in 1 BAG",
"NDC11Code": "53877-0001-04",
"ProductNDC": "53877-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
"NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20091214",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "BN820528",
"LabelerName": "Terumo Corporation",
"SubstanceName": "ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
"StrengthNumber": ".275; 2.99; 31.9; 2.22; 26.3",
"StrengthUnit": "g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL",
"Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20091214",
"SamplePackage": "N",
"IndicationAndUsage": "FULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 7, 8, 9, 10, 12, 13, 14, 15 and 17].1. INDICATIONS AND USAGE1.1. Read these instructions carefully before use.1.2. Rx ONLY.1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4. For the collection of 450 mL ±10% or 500 mL ±10% Whole Blood.1.5. Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit.1.6. For further processing, use standard component processing techniques.",
"Description": "11. DESCRIPTION / PRODUCT SPECIFICATIONS. 11.1. This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and either a 450 mL or 500 mL (nominal capacity 600 mL) primary collection bag containing 63 mL or 70 mL, respectively, Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant, The Double blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL). The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). The Quadruple blood bag set has two integrally attached empty satellite bags (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2. Blood bag codes ending in A4 are supplied with Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit. 11.3. Blood bag codes ending in A3 also include a DonorCare Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4. The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5. The blood bag has no components made of natural rubber latex. 11.6. Tubing internal diameter (ID) nominal 3.0 mm. 11.7. Tubing outer diameter (OD) nominal 4.4 mm. 11.8. Donor tubing line maximum 16 segments available."
},
{
"NDCCode": "53877-001-05",
"PackageDescription": "30 BAG in 1 CASE (53877-001-05) > 63 mL in 1 BAG",
"NDC11Code": "53877-0001-05",
"ProductNDC": "53877-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
"NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20091214",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "BN820528",
"LabelerName": "Terumo Corporation",
"SubstanceName": "ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
"StrengthNumber": ".275; 2.99; 31.9; 2.22; 26.3",
"StrengthUnit": "g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL",
"Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20091214",
"SamplePackage": "N",
"IndicationAndUsage": "FULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 7, 8, 9, 10, 12, 13, 14, 15 and 17].1. INDICATIONS AND USAGE1.1. Read these instructions carefully before use.1.2. Rx ONLY.1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4. For the collection of 450 mL ±10% or 500 mL ±10% Whole Blood.1.5. Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit.1.6. For further processing, use standard component processing techniques.",
"Description": "11. DESCRIPTION / PRODUCT SPECIFICATIONS. 11.1. This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and either a 450 mL or 500 mL (nominal capacity 600 mL) primary collection bag containing 63 mL or 70 mL, respectively, Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant, The Double blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL). The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). The Quadruple blood bag set has two integrally attached empty satellite bags (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2. Blood bag codes ending in A4 are supplied with Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit. 11.3. Blood bag codes ending in A3 also include a DonorCare Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4. The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5. The blood bag has no components made of natural rubber latex. 11.6. Tubing internal diameter (ID) nominal 3.0 mm. 11.7. Tubing outer diameter (OD) nominal 4.4 mm. 11.8. Donor tubing line maximum 16 segments available."
},
{
"NDCCode": "53877-001-06",
"PackageDescription": "36 BAG in 1 CASE (53877-001-06) > 70 mL in 1 BAG",
"NDC11Code": "53877-0001-06",
"ProductNDC": "53877-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
"NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20091214",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "BN820528",
"LabelerName": "Terumo Corporation",
"SubstanceName": "ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
"StrengthNumber": ".275; 2.99; 31.9; 2.22; 26.3",
"StrengthUnit": "g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL",
"Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20091214",
"SamplePackage": "N",
"IndicationAndUsage": "FULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 7, 8, 9, 10, 12, 13, 14, 15 and 17].1. INDICATIONS AND USAGE1.1. Read these instructions carefully before use.1.2. Rx ONLY.1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4. For the collection of 450 mL ±10% or 500 mL ±10% Whole Blood.1.5. Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit.1.6. For further processing, use standard component processing techniques.",
"Description": "11. DESCRIPTION / PRODUCT SPECIFICATIONS. 11.1. This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and either a 450 mL or 500 mL (nominal capacity 600 mL) primary collection bag containing 63 mL or 70 mL, respectively, Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant, The Double blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL). The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). The Quadruple blood bag set has two integrally attached empty satellite bags (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2. Blood bag codes ending in A4 are supplied with Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit. 11.3. Blood bag codes ending in A3 also include a DonorCare Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4. The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5. The blood bag has no components made of natural rubber latex. 11.6. Tubing internal diameter (ID) nominal 3.0 mm. 11.7. Tubing outer diameter (OD) nominal 4.4 mm. 11.8. Donor tubing line maximum 16 segments available."
},
{
"NDCCode": "53877-001-07",
"PackageDescription": "30 BAG in 1 CASE (53877-001-07) > 70 mL in 1 BAG",
"NDC11Code": "53877-0001-07",
"ProductNDC": "53877-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
"NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20091214",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "BN820528",
"LabelerName": "Terumo Corporation",
"SubstanceName": "ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
"StrengthNumber": ".275; 2.99; 31.9; 2.22; 26.3",
"StrengthUnit": "g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL",
"Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20091214",
"SamplePackage": "N",
"IndicationAndUsage": "FULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 7, 8, 9, 10, 12, 13, 14, 15 and 17].1. INDICATIONS AND USAGE1.1. Read these instructions carefully before use.1.2. Rx ONLY.1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4. For the collection of 450 mL ±10% or 500 mL ±10% Whole Blood.1.5. Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit.1.6. For further processing, use standard component processing techniques.",
"Description": "11. DESCRIPTION / PRODUCT SPECIFICATIONS. 11.1. This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and either a 450 mL or 500 mL (nominal capacity 600 mL) primary collection bag containing 63 mL or 70 mL, respectively, Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant, The Double blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL). The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). The Quadruple blood bag set has two integrally attached empty satellite bags (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2. Blood bag codes ending in A4 are supplied with Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit. 11.3. Blood bag codes ending in A3 also include a DonorCare Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4. The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5. The blood bag has no components made of natural rubber latex. 11.6. Tubing internal diameter (ID) nominal 3.0 mm. 11.7. Tubing outer diameter (OD) nominal 4.4 mm. 11.8. Donor tubing line maximum 16 segments available."
},
{
"NDCCode": "53877-001-08",
"PackageDescription": "24 BAG in 1 CASE (53877-001-08) > 70 mL in 1 BAG",
"NDC11Code": "53877-0001-08",
"ProductNDC": "53877-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
"NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20091214",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "BN820528",
"LabelerName": "Terumo Corporation",
"SubstanceName": "ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
"StrengthNumber": ".275; 2.99; 31.9; 2.22; 26.3",
"StrengthUnit": "g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL",
"Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20091214",
"SamplePackage": "N",
"IndicationAndUsage": "FULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 7, 8, 9, 10, 12, 13, 14, 15 and 17].1. INDICATIONS AND USAGE1.1. Read these instructions carefully before use.1.2. Rx ONLY.1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4. For the collection of 450 mL ±10% or 500 mL ±10% Whole Blood.1.5. Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit.1.6. For further processing, use standard component processing techniques.",
"Description": "11. DESCRIPTION / PRODUCT SPECIFICATIONS. 11.1. This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and either a 450 mL or 500 mL (nominal capacity 600 mL) primary collection bag containing 63 mL or 70 mL, respectively, Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant, The Double blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL). The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). The Quadruple blood bag set has two integrally attached empty satellite bags (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2. Blood bag codes ending in A4 are supplied with Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit. 11.3. Blood bag codes ending in A3 also include a DonorCare Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4. The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5. The blood bag has no components made of natural rubber latex. 11.6. Tubing internal diameter (ID) nominal 3.0 mm. 11.7. Tubing outer diameter (OD) nominal 4.4 mm. 11.8. Donor tubing line maximum 16 segments available."
},
{
"NDCCode": "53877-001-09",
"PackageDescription": "24 BAG in 1 CASE (53877-001-09) > 63 mL in 1 BAG",
"NDC11Code": "53877-0001-09",
"ProductNDC": "53877-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
"NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20091214",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "BN820528",
"LabelerName": "Terumo Corporation",
"SubstanceName": "ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
"StrengthNumber": ".275; 2.99; 31.9; 2.22; 26.3",
"StrengthUnit": "g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL",
"Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20091214",
"SamplePackage": "N",
"IndicationAndUsage": "FULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 7, 8, 9, 10, 12, 13, 14, 15 and 17].1. INDICATIONS AND USAGE1.1. Read these instructions carefully before use.1.2. Rx ONLY.1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4. For the collection of 450 mL ±10% or 500 mL ±10% Whole Blood.1.5. Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit.1.6. For further processing, use standard component processing techniques.",
"Description": "11. DESCRIPTION / PRODUCT SPECIFICATIONS. 11.1. This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and either a 450 mL or 500 mL (nominal capacity 600 mL) primary collection bag containing 63 mL or 70 mL, respectively, Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant, The Double blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL). The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). The Quadruple blood bag set has two integrally attached empty satellite bags (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2. Blood bag codes ending in A4 are supplied with Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit. 11.3. Blood bag codes ending in A3 also include a DonorCare Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4. The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5. The blood bag has no components made of natural rubber latex. 11.6. Tubing internal diameter (ID) nominal 3.0 mm. 11.7. Tubing outer diameter (OD) nominal 4.4 mm. 11.8. Donor tubing line maximum 16 segments available."
},
{
"NDCCode": "53877-001-10",
"PackageDescription": "36 BAG in 1 CASE (53877-001-10) > 63 mL in 1 BAG",
"NDC11Code": "53877-0001-10",
"ProductNDC": "53877-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
"NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20091214",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "BN820528",
"LabelerName": "Terumo Corporation",
"SubstanceName": "ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
"StrengthNumber": ".275; 2.99; 31.9; 2.22; 26.3",
"StrengthUnit": "g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL",
"Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20091214",
"SamplePackage": "N",
"IndicationAndUsage": "FULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 7, 8, 9, 10, 12, 13, 14, 15 and 17].1. INDICATIONS AND USAGE1.1. Read these instructions carefully before use.1.2. Rx ONLY.1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4. For the collection of 450 mL ±10% or 500 mL ±10% Whole Blood.1.5. Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit.1.6. For further processing, use standard component processing techniques.",
"Description": "11. DESCRIPTION / PRODUCT SPECIFICATIONS. 11.1. This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and either a 450 mL or 500 mL (nominal capacity 600 mL) primary collection bag containing 63 mL or 70 mL, respectively, Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant, The Double blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL). The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). The Quadruple blood bag set has two integrally attached empty satellite bags (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2. Blood bag codes ending in A4 are supplied with Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit. 11.3. Blood bag codes ending in A3 also include a DonorCare Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4. The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5. The blood bag has no components made of natural rubber latex. 11.6. Tubing internal diameter (ID) nominal 3.0 mm. 11.7. Tubing outer diameter (OD) nominal 4.4 mm. 11.8. Donor tubing line maximum 16 segments available."
},
{
"NDCCode": "53877-001-11",
"PackageDescription": "30 BAG in 1 CASE (53877-001-11) > 63 mL in 1 BAG",
"NDC11Code": "53877-0001-11",
"ProductNDC": "53877-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
"NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120522",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "BN820528",
"LabelerName": "Terumo Corporation",
"SubstanceName": "ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
"StrengthNumber": ".275; 2.99; 31.9; 2.22; 26.3",
"StrengthUnit": "g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL",
"Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20120522",
"SamplePackage": "N",
"IndicationAndUsage": "Issued 2011-11 N-BB-CA-A-DB(2)BB89X404+2TERUFLEX BLOOD BAG SYSTEM with Diversion Blood Sampling ArmCPDA-1 SOLUTIONFor the collection of 450 mL and 500 mL of Whole BloodFULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 8, 9, 10, 12, 13, 14, 15 and 17].1. INDICATIONS AND USAGE1.1. Read these instructions carefully before use.1.2. Rx ONLY1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4. For the collection of 450 mL +/- 10% and 500 mL +/- 10% Whole Blood.1.5. Integral Diversion Blood Sampling Arm is intended to divert and obtain donor samples for laboratory testing prior to collection of the whole blood unit.1.6. For further processing, use standard component processing techniques.",
"Description": "11. DESCRIPTION/PRODUCT SPECIFICATIONS. 11.1. This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and either 450 mL or 500 mL (nominal capacity 600 mL) primary collection bag containing 63 mL or 70 mL, respectively, Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant. The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). The Quadruple blood bag set has two integrally attached empty satellite bags (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2. Blood bag codes ending in A2 are supplied with Integral Diversion Blood Sampling Arm intended to divert and obtain donor samples for laboratory testing prior to collection of the Whole Blood unit. 11.3. Blood bag codes ending in A2 also include a DonorCare Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4. The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5. The blood bag has no components made of natural rubber latex. 11.6. Tubing internal diameter (ID) nominal 3.0 mm. 11.7. Tubing outer diameter (OD) nominal 4.4 mm. 11.8. Donor tubing line maximum 16 segments available."
},
{
"NDCCode": "53877-001-12",
"PackageDescription": "24 BAG in 1 CASE (53877-001-12) > 63 mL in 1 BAG",
"NDC11Code": "53877-0001-12",
"ProductNDC": "53877-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
"NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120522",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "BN820528",
"LabelerName": "Terumo Corporation",
"SubstanceName": "ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
"StrengthNumber": ".275; 2.99; 31.9; 2.22; 26.3",
"StrengthUnit": "g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL",
"Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20120522",
"SamplePackage": "N",
"IndicationAndUsage": "Issued 2011-11 N-BB-CA-A-DB(2)BB89X404+2TERUFLEX BLOOD BAG SYSTEM with Diversion Blood Sampling ArmCPDA-1 SOLUTIONFor the collection of 450 mL and 500 mL of Whole BloodFULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 8, 9, 10, 12, 13, 14, 15 and 17].1. INDICATIONS AND USAGE1.1. Read these instructions carefully before use.1.2. Rx ONLY1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4. For the collection of 450 mL +/- 10% and 500 mL +/- 10% Whole Blood.1.5. Integral Diversion Blood Sampling Arm is intended to divert and obtain donor samples for laboratory testing prior to collection of the whole blood unit.1.6. For further processing, use standard component processing techniques.",
"Description": "11. DESCRIPTION/PRODUCT SPECIFICATIONS. 11.1. This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and either 450 mL or 500 mL (nominal capacity 600 mL) primary collection bag containing 63 mL or 70 mL, respectively, Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant. The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). The Quadruple blood bag set has two integrally attached empty satellite bags (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2. Blood bag codes ending in A2 are supplied with Integral Diversion Blood Sampling Arm intended to divert and obtain donor samples for laboratory testing prior to collection of the Whole Blood unit. 11.3. Blood bag codes ending in A2 also include a DonorCare Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4. The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5. The blood bag has no components made of natural rubber latex. 11.6. Tubing internal diameter (ID) nominal 3.0 mm. 11.7. Tubing outer diameter (OD) nominal 4.4 mm. 11.8. Donor tubing line maximum 16 segments available."
},
{
"NDCCode": "53877-001-13",
"PackageDescription": "30 BAG in 1 CASE (53877-001-13) > 70 mL in 1 BAG",
"NDC11Code": "53877-0001-13",
"ProductNDC": "53877-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
"NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120522",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "BN820528",
"LabelerName": "Terumo Corporation",
"SubstanceName": "ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
"StrengthNumber": ".275; 2.99; 31.9; 2.22; 26.3",
"StrengthUnit": "g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL",
"Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20120522",
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"IndicationAndUsage": "Issued 2011-11 N-BB-CA-A-DB(2)BB89X404+2TERUFLEX BLOOD BAG SYSTEM with Diversion Blood Sampling ArmCPDA-1 SOLUTIONFor the collection of 450 mL and 500 mL of Whole BloodFULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 8, 9, 10, 12, 13, 14, 15 and 17].1. INDICATIONS AND USAGE1.1. Read these instructions carefully before use.1.2. Rx ONLY1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4. For the collection of 450 mL +/- 10% and 500 mL +/- 10% Whole Blood.1.5. Integral Diversion Blood Sampling Arm is intended to divert and obtain donor samples for laboratory testing prior to collection of the whole blood unit.1.6. For further processing, use standard component processing techniques.",
"Description": "11. DESCRIPTION/PRODUCT SPECIFICATIONS. 11.1. This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and either 450 mL or 500 mL (nominal capacity 600 mL) primary collection bag containing 63 mL or 70 mL, respectively, Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant. The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). The Quadruple blood bag set has two integrally attached empty satellite bags (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2. Blood bag codes ending in A2 are supplied with Integral Diversion Blood Sampling Arm intended to divert and obtain donor samples for laboratory testing prior to collection of the Whole Blood unit. 11.3. Blood bag codes ending in A2 also include a DonorCare Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4. The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5. The blood bag has no components made of natural rubber latex. 11.6. Tubing internal diameter (ID) nominal 3.0 mm. 11.7. Tubing outer diameter (OD) nominal 4.4 mm. 11.8. Donor tubing line maximum 16 segments available."
},
{
"NDCCode": "53877-001-14",
"PackageDescription": "24 BAG in 1 CASE (53877-001-14) > 70 mL in 1 BAG",
"NDC11Code": "53877-0001-14",
"ProductNDC": "53877-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
"NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120522",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "BN820528",
"LabelerName": "Terumo Corporation",
"SubstanceName": "ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
"StrengthNumber": ".275; 2.99; 31.9; 2.22; 26.3",
"StrengthUnit": "g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL",
"Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20120522",
"SamplePackage": "N",
"IndicationAndUsage": "Issued 2011-11 N-BB-CA-A-DB(2)BB89X404+2TERUFLEX BLOOD BAG SYSTEM with Diversion Blood Sampling ArmCPDA-1 SOLUTIONFor the collection of 450 mL and 500 mL of Whole BloodFULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 8, 9, 10, 12, 13, 14, 15 and 17].1. INDICATIONS AND USAGE1.1. Read these instructions carefully before use.1.2. Rx ONLY1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4. For the collection of 450 mL +/- 10% and 500 mL +/- 10% Whole Blood.1.5. Integral Diversion Blood Sampling Arm is intended to divert and obtain donor samples for laboratory testing prior to collection of the whole blood unit.1.6. For further processing, use standard component processing techniques.",
"Description": "11. DESCRIPTION/PRODUCT SPECIFICATIONS. 11.1. This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and either 450 mL or 500 mL (nominal capacity 600 mL) primary collection bag containing 63 mL or 70 mL, respectively, Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant. The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). The Quadruple blood bag set has two integrally attached empty satellite bags (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2. Blood bag codes ending in A2 are supplied with Integral Diversion Blood Sampling Arm intended to divert and obtain donor samples for laboratory testing prior to collection of the Whole Blood unit. 11.3. Blood bag codes ending in A2 also include a DonorCare Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4. The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5. The blood bag has no components made of natural rubber latex. 11.6. Tubing internal diameter (ID) nominal 3.0 mm. 11.7. Tubing outer diameter (OD) nominal 4.4 mm. 11.8. Donor tubing line maximum 16 segments available."
},
{
"NDCCode": "53877-005-01",
"PackageDescription": "30 BAG in 1 CASE (53877-005-01) / 1 KIT in 1 BAG * 35 mL in 1 BAG * 56 mL in 1 BAG",
"NDC11Code": "53877-0005-01",
"ProductNDC": "53877-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol Red Cell Preservative",
"NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative",
"DosageFormName": "KIT",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20091215",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "BN880217",
"LabelerName": "Terumo Corporation",
"Status": "Deprecated",
"LastUpdate": "2025-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20091215",
"SamplePackage": "N"
},
{
"NDCCode": "53877-005-21",
"PackageDescription": "24 BAG in 1 CASE (53877-005-21) > 1 KIT in 1 BAG * 63 mL in 1 BAG * 100 mL in 1 BAG",
"NDC11Code": "53877-0005-21",
"ProductNDC": "53877-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol Red Cell Preservative",
"NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative",
"DosageFormName": "KIT",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20100113",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "BN880217",
"LabelerName": "Terumo Corporation",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20100113",
"SamplePackage": "N",
"IndicationAndUsage": "Revised 8/96TERUFLEX® BLOOD BAG SYSTEMCPD/OPTISOL® SOLUTIONRead these instructions before use.INSTRUCTIONS FOR BLOOD COLLECTION: Use aseptic technique1. Confirm that all numbered tubing of each blood bag unit contains segment numbers.2. Make a loose knot in the donor tubing approximately 10 cm from needle unless alternate methods are used to seal tubing.3. Clamp donor tubing.4. Suspend primary bag as far as possible below the donor's arm.5. Apply blood pressure cuff or tourniquiet to donor's arm. Disinfect site of phlebotomy. If blood pressure cuff is used, inflate cuff to 60 mmHg.6. Remove needle protector and perform phlebotomy. Remove clamp to permit blood flow into primary bag. CAUTION Do not touch needle after removing the needle protector.7. Appropriately secure donor tubing to donor's arm.8. MIX BLOOD WITH ANTICOAGULANT AT SEVERAL INTERVALS DURING COLLECTION.9. Collect labeled volume of blood (+/- 10%).10. Tighten knot firmly after collection. Clamp between knot and needle. Sever donor tubing between knot and clamp. Collect blood samples.11. Reapply clamp to donor tubing; release pressure on donor's arm and remove needle. Seal donor tubing. CAUTION Discard tubing/phlebotomy needle unit according to institutional procedures.12. Immediately after collection, invert bag several times to assure blood and anticoagulant are well mixed.13. Strip blood from donor tubing into bag, mix well, and allow tubing to refill. Seal on or near X marks on donor tubing to provide numbered aliquots of anticoagulated blood for testing.14. Centrifuge unit to separate red cells from plasma.15.The time of addition of OPTISOL Solution may vary depending on the processing option selected. Add solution under one of the following conditions.a) After removal of plasma from freshly collected blood.b) Within 8 hours of blood collection if components are prepared.c) Within 72 hours of collection if blood is refrigerated immediately following collection.16. Snap CLIKTIP (incline closure device) of primary collection bag and transfer plasma into satellite bag. Clamp transfer tubing of satellite bag.17. Snap CLIKTIP of OPTISOL Solution bag and drain contents into primary bag containing red blood cells. Seal tubing of primary bag in two places, and cut between seals and separate from satellite bag(s).NOTE: For TERUFLEX double bags, seal OPTISOL Solution bag tubing in two places, and cut between seals. Discard OPTISOL Solution container.18. Invert the red cell- OPTISOL mixture several times to insure that the final AS-5 red cell product is well suspended.19. Store AS-5 Red Blood Cells between 1-6oC.20. Infuse AS-5 Red Blood Cells within 42 days of collection.For further processing, use standard component processing techniques.To open the blister package, peel the cover film back 4/5 of its length.After opening, unused bags may be stored for 30 days by returning cover film to original position and sealing with tape to prevent possible loss of moisture. CAUTIONS THE PACKET OF AGELESS CONTAINED IN THIS PACKAGE ABSORBS OXYGEN AND GENERATES HEAT ON REMOVAL AND SHOULD BE HANDLED WITH CARE. DISPOSE WITH PACKET IN TRAY. DO NOT DISPOSE WITH WASTES CONTAINING VOLATILE OR FLAMMABLE MATERIALS. DISCARD AGELESS PACKET WITHOUT OPENING.TERUMO CORPORATION44-1, 2-chome, Hatagaya, Shibuya-Ku, Tokyo, Japan®: Registered TrademarkN-BB-OP-A (4)."
}
]
}
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<NDCList>
<NDC>
<NDCCode>53877-008-81</NDCCode>
<PackageDescription>18 BAG in 1 CASE (53877-008-81) > 1 KIT in 1 BAG * 63 mL in 1 BAG * 100 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0008-81</NDC11Code>
<ProductNDC>53877-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System With Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative</ProprietaryName>
<NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20100505</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN880217</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Issued 6/03 TERUFLEX® BLOOD BAG SYSTEM With DIVERSION BLOOD SAMPLING ARM® CPD/OPTISOL® SOLUTIONRead these instructions carefully before use. Rx ONLY.The Diversion Blood Sampling Arm is intended to divert and collect blood for obtaining donor test samples. For single use only. Sterile and non-pyrogenic fluid path. Sterilized by steam. Intended for the collection, processing and preservation of human blood and components.PRECAUTIONS Do not use unless the solutions are clear. Avoid excessive heat and direct sunlight. Protect from freezing. Recommended storage conditions: Room Temperature (15-30°C/59-86°F). The blood bag configuration is specified on the blister pack label.CAUTION Do not use a dielectric tube sealer to seal the tubing while the needle is connected to the donor's body unless it is approved for such a purpose.INSTRUCTIONS FOR BLOOD COLLECTION: Use aseptic techniqueMaterials Needed: VENOJECT® ll Tube Holder (code P-1316R) or equivalentVENOJECT® ll Multi-Sample Luer Adapter (code MN *2000T) or equivalentEvacuated Blood Collection Tubes (glass or plastic)1. Prepare the blood bag following your institution's standard operating procedures.2. If applicable, make a loose knot in the donor tubing below the "Y" and CLIKTIP (inline closure device) unless alternate methods are used to seal the tubing at the end of collection.3. Temporarily clamp the donor tubing between the phlebotomy needle and the "Y".4. Close the White Clamp below the diversion pouch.5. Tube Holder/Luer Adapter Assembly:a) Connect the VENOJECT II Multi-Sample Luer Adapter to the VENOJECT II Tube Holder (or equivalent) (Fig.1).Insert Fig. 1 here. b) Twist and snap to remove the blue port cap at the end of the Diversion Blood sampling Arm (Fig. 2a).c) Connect the multi-sample luer adapter to the female luer port. (Fig. 2b)NOTE: Alternatively, steps a, b and c (above) may be performed at any time during bag preparation or after the blood is collected into the diversion pouch.Insert Fig. 2a and 2b here. 6. Suspend the collection bag as far as possible below the donor's arm.7. Apply blood pressure cuff or tourniquet to donor's arm. Disinfect site of phlebotomy. If blood pressure cuff is used, inflate to approximately 60 mmHg.8. Remove the needle cover and perform phlebotomy. Remove the temporary clamp on the donor tubing to permit blood flow into the Diversion Blood Sampling Arm pouch.CAUTION Do not touch the needle after removing the needle protector. Assure that the White Clamp below the pouch is closed prior to initiating phlebotomy.9. If using a needle safety device, follow the manufacturer's instructions to secure the device in place.10. Appropriately secure donor tubing to donor's arm.11. Position the diversion pouch with the notches up and the Tube Holder/Luer Adapter assembly (or port cap) down. When the level of blood in the pouch is approximately in linewith the notches, the diversion pouch is full. (Fig. 3a)NOTE: The approximate fill volume of the pouch at the notches is 35 mL.12. Permanently seal the tubing between the "Y" and the diversion pouch to maintain a closed system using an aluminum clip or a tube sealer approved for use with tubing connected to a donor. (Fig. 3b)13. To initiate blood flow into the collection bag, break the CLlKTIP between the "Y" and the primary bag.14. To avoid clot formation, collect samples as soon as possible from the diversion pouch as follows (Fig. 3b)CAUTION Do not collect donor test samples until the tubing between the "Y" and the diversion pouch is permanently sealed.a) Open the White Clamp on the tubing below the pouch to open the pathway for sampling.b) Position the diversion pouch with the notches up and the Tube Holder/Luer Adapter assembly down. Assure that any air in the pouch is at the top and will not enter theblood collection tubes.c) Insert vacuum blood collection tube firmly into the tube holder; when full, remove sample tube from holder. Repeat to collect additional samples.NOTE: The pouch may be removed after the donor test samples are collected. A second seal must be made between the diversion pouch and the permanent sealprior to removing the pouch.Insert Fig. 3a and 3b here. 15. Once samples are obtained, mix blood with anticoagulant in the primary bag and continue to mix at several intervals during collection. 16. Collect labeled volume of blood (+/–10%).17. When the desired amount of blood has been collected, seal the tubing or tighten the loose knot (white knot) prepared in step 2. Make a second seal between the first seal or knot andthe CLlKTIP below the "Y". Various methods may be used to seal tubing.18. Release pressure on the donor's arm and remove the needle. If using a needle safety device, follow the manufacturer's instructions to remove the needle. Sever the donor tubing between the two seals previously made below the CLlKTIP and "Y".CAUTION Discard the Diversion Blood Sampling Arm and phlebotomy needle/donor tubing according to institutional procedures.19. Immediately after collection, invert the bag several times to assure blood and anticoagulant are well mixed.20. Strip blood from the donor tubing into the bag, mix well, and allow tubing to refill. Seal on or near the X marks on the donor tubing to provide numbered aliquots of anticoagulated blood for testing.21. The time of addition of OPTISOL Solution may vary depending on the processing option selected. Add the solution under one of the following conditions after removal of plasma:a) Within 8 hours of whole blood collection, if components are prepared.b) Within 72 hours of collection if whole blood is refrigerated immediately following collection.22. Centrifuge the unit to separate red cells from plasma.23. Break the CLlKTIP of primary collection bag and transfer the plasma into the satellite bag. Clamp transfer tubing of satellite bag.24. Break the CLlKTIP of OPTlSOL Solution bag and drain contents into primary bag containing red blood cells. Seal tubing of primary bag in two places, and cut between sealsand separate from satellite bag(s).NOTE: For TERUFLEX double bags, seal OPTISOL Solution bag tubing in two places and cut between seals. Discard OPTISOL Solution container.25. Invert the red cell- OPTISOL mixture several times to insure the final AS-5 red cell product is well suspended.26. Store AS-5 Red Blood Cells between 1-6°C.27. Infuse AS-5 Red Blood Cells within 42 days of collection.For further processing, use standard component processing techniques.To open blister package, peel cover film back four fifths of its length. After opening, unused bags may be stored for 30 days by returning cover film to original position and sealing with tape to prevent possible loss of moisture.Insert Fig. 4 here. CAUTIONSThe packet of AGELESS contained in this package absorbs oxygen and generates heat on removal. Handle it with care. Dispose with packet in tray. Do not dispose with wastes containing volatile or flammable materials. Discard AGELESS packet without opening.N-BB-OP-A2(DB) 1TERUMO® MANUFACTURED BY: TERUMO CORPORATION 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO, JAPAN MADE IN JAPAN®: Registered Trademark Diversion Blood Sampling Arm and CLIKTIP are trademarks of TERUMO CORPORATION.© TERUMO CORPORATION 2003 03F10.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>53877-008-51</NDCCode>
<PackageDescription>24 BAG in 1 CASE (53877-008-51) > 1 KIT in 1 BAG * 63 mL in 1 BAG * 100 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0008-51</NDC11Code>
<ProductNDC>53877-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System With Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative</ProprietaryName>
<NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20100505</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN880217</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Issued 6/03 TERUFLEX® BLOOD BAG SYSTEM With DIVERSION BLOOD SAMPLING ARM® CPD/OPTISOL® SOLUTIONRead these instructions carefully before use. Rx ONLY.The Diversion Blood Sampling Arm is intended to divert and collect blood for obtaining donor test samples. For single use only. Sterile and non-pyrogenic fluid path. Sterilized by steam. Intended for the collection, processing and preservation of human blood and components.PRECAUTIONS Do not use unless the solutions are clear. Avoid excessive heat and direct sunlight. Protect from freezing. Recommended storage conditions: Room Temperature (15-30°C/59-86°F). The blood bag configuration is specified on the blister pack label.CAUTION Do not use a dielectric tube sealer to seal the tubing while the needle is connected to the donor's body unless it is approved for such a purpose.INSTRUCTIONS FOR BLOOD COLLECTION: Use aseptic techniqueMaterials Needed: VENOJECT® ll Tube Holder (code P-1316R) or equivalentVENOJECT® ll Multi-Sample Luer Adapter (code MN *2000T) or equivalentEvacuated Blood Collection Tubes (glass or plastic)1. Prepare the blood bag following your institution's standard operating procedures.2. If applicable, make a loose knot in the donor tubing below the "Y" and CLIKTIP (inline closure device) unless alternate methods are used to seal the tubing at the end of collection.3. Temporarily clamp the donor tubing between the phlebotomy needle and the "Y".4. Close the White Clamp below the diversion pouch.5. Tube Holder/Luer Adapter Assembly:a) Connect the VENOJECT II Multi-Sample Luer Adapter to the VENOJECT II Tube Holder (or equivalent) (Fig.1).Insert Fig. 1 hereb) Twist and snap to remove the blue port cap at the end of the Diversion Blood sampling Arm (Fig. 2a).c) Connect the multi-sample luer adapter to the female luer port. (Fig. 2b)NOTE: Alternatively, steps a, b and c (above) may be performed at any time during bag preparation or after the blood is collected into the diversion pouch.Insert Fig. 2a and 2b here6. Suspend the collection bag as far as possible below the donor's arm.7. Apply blood pressure cuff or tourniquet to donor's arm. Disinfect site of phlebotomy. If blood pressure cuff is used, inflate to approximately 60 mmHg.8. Remove the needle cover and perform phlebotomy. Remove the temporary clamp on the donor tubing to permit blood flow into the Diversion Blood Sampling Arm pouch.CAUTION Do not touch the needle after removing the needle protector. Assure that the White Clamp below the pouch is closed prior to initiating phlebotomy.9. If using a needle safety device, follow the manufacturer's instructions to secure the device in place.10. Appropriately secure donor tubing to donor's arm.11. Position the diversion pouch with the notches up and the Tube Holder/Luer Adapter assembly (or port cap) down. When the level of blood in the pouch is approximately in linewith the notches, the diversion pouch is full. (Fig. 3a)NOTE: The approximate fill volume of the pouch at the notches is 35 mL.12. Permanently seal the tubing between the "Y" and the diversion pouch to maintain a closed system using an aluminum clip or a tube sealer approved for use with tubing connected to a donor. (Fig. 3b)13. To initiate blood flow into the collection bag, break the CLlKTIP between the "Y" and the primary bag.14. To avoid clot formation, collect samples as soon as possible from the diversion pouch as follows (Fig. 3b)CAUTION Do not collect donor test samples until the tubing between the "Y" and the diversion pouch is permanently sealed.a) Open the White Clamp on the tubing below the pouch to open the pathway for sampling.b) Position the diversion pouch with the notches up and the Tube Holder/Luer Adapter assembly down. Assure that any air in the pouch is at the top and will not enter theblood collection tubes.c) Insert vacuum blood collection tube firmly into the tube holder; when full, remove sample tube from holder. Repeat to collect additional samples.NOTE: The pouch may be removed after the donor test samples are collected. A second seal must be made between the diversion pouch and the permanent sealprior to removing the pouch.Insert Fig. 3a and 3b here15. Once samples are obtained, mix blood with anticoagulant in the primary bag and continue to mix at several intervals during collection. 16. Collect labeled volume of blood (+/–10%).17. When the desired amount of blood has been collected, seal the tubing or tighten the loose knot (white knot) prepared in step 2. Make a second seal between the first seal or knot andthe CLlKTIP below the "Y". Various methods may be used to seal tubing.18. Release pressure on the donor's arm and remove the needle. If using a needle safety device, follow the manufacturer's instructions to remove the needle. Sever the donor tubing between the two seals previously made below the CLlKTIP and "Y".CAUTION Discard the Diversion Blood Sampling Arm and phlebotomy needle/donor tubing according to institutional procedures.19. Immediately after collection, invert the bag several times to assure blood and anticoagulant are well mixed.20. Strip blood from the donor tubing into the bag, mix well, and allow tubing to refill. Seal on or near the X marks on the donor tubing to provide numbered aliquots of anticoagulated blood for testing.21. The time of addition of OPTISOL Solution may vary depending on the processing option selected. Add the solution under one of the following conditions after removal of plasma:a) Within 8 hours of whole blood collection, if components are prepared.b) Within 72 hours of collection if whole blood is refrigerated immediately following collection.22. Centrifuge the unit to separate red cells from plasma.23. Break the CLlKTIP of primary collection bag and transfer the plasma into the satellite bag. Clamp transfer tubing of satellite bag.24. Break the CLlKTIP of OPTlSOL Solution bag and drain contents into primary bag containing red blood cells. Seal tubing of primary bag in two places, and cut between sealsand separate from satellite bag(s).NOTE: For TERUFLEX double bags, seal OPTISOL Solution bag tubing in two places and cut between seals. Discard OPTISOL Solution container.25. Invert the red cell- OPTISOL mixture several times to insure the final AS-5 red cell product is well suspended.26. Store AS-5 Red Blood Cells between 1-6°C.27. Infuse AS-5 Red Blood Cells within 42 days of collection.For further processing, use standard component processing techniques.To open blister package, peel cover film back four fifths of its length. After opening, unused bags may be stored for 30 days by returning cover film to original position and sealing with tape to prevent possible loss of moisture.Insert Fig. 4 hereCAUTIONSThe packet of AGELESS contained in this package absorbs oxygen and generates heat on removal. Handle it with care. Dispose with packet in tray. Do not dispose with wastes containing volatile or flammable materials. Discard AGELESS packet without opening.N-BB-OP-A2(DB) 1TERUMO® MANUFACTURED BY: TERUMO CORPORATION 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO, JAPAN MADE IN JAPAN®: Registered Trademark Diversion Blood Sampling Arm and CLIKTIP are trademarks of TERUMO CORPORATION.© TERUMO CORPORATION 2003 03F10.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>53877-008-61</NDCCode>
<PackageDescription>24 BAG in 1 CASE (53877-008-61) > 1 KIT in 1 BAG * 70 mL in 1 BAG * 111 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0008-61</NDC11Code>
<ProductNDC>53877-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System With Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative</ProprietaryName>
<NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20100505</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN880217</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Issued 6/03 TERUFLEX® BLOOD BAG SYSTEM With DIVERSION BLOOD SAMPLING ARM® CPD/OPTISOL® SOLUTIONRead these instructions carefully before use. Rx ONLY.The Diversion Blood Sampling Arm is intended to divert and collect blood for obtaining donor test samples. For single use only. Sterile and non-pyrogenic fluid path. Sterilized by steam. Intended for the collection, processing and preservation of human blood and components.PRECAUTIONS Do not use unless the solutions are clear. Avoid excessive heat and direct sunlight. Protect from freezing. Recommended storage conditions: Room Temperature (15-30°C/59-86°F). The blood bag configuration is specified on the blister pack label.CAUTION Do not use a dielectric tube sealer to seal the tubing while the needle is connected to the donor's body unless it is approved for such a purpose.INSTRUCTIONS FOR BLOOD COLLECTION: Use aseptic techniqueMaterials Needed: VENOJECT® ll Tube Holder (code P-1316R) or equivalentVENOJECT® ll Multi-Sample Luer Adapter (code MN *2000T) or equivalentEvacuated Blood Collection Tubes (glass or plastic)1. Prepare the blood bag following your institution's standard operating procedures.2. If applicable, make a loose knot in the donor tubing below the "Y" and CLIKTIP (inline closure device) unless alternate methods are used to seal the tubing at the end of collection.3. Temporarily clamp the donor tubing between the phlebotomy needle and the "Y".4. Close the White Clamp below the diversion pouch.5. Tube Holder/Luer Adapter Assembly:a) Connect the VENOJECT II Multi-Sample Luer Adapter to the VENOJECT II Tube Holder (or equivalent) (Fig.1).Insert Fig. 1 hereb) Twist and snap to remove the blue port cap at the end of the Diversion Blood sampling Arm (Fig. 2a).c) Connect the multi-sample luer adapter to the female luer port. (Fig. 2b)NOTE: Alternatively, steps a, b and c (above) may be performed at any time during bag preparation or after the blood is collected into the diversion pouch.Insert Fig. 2a and 2b here6. Suspend the collection bag as far as possible below the donor's arm.7. Apply blood pressure cuff or tourniquet to donor's arm. Disinfect site of phlebotomy. If blood pressure cuff is used, inflate to approximately 60 mmHg.8. Remove the needle cover and perform phlebotomy. Remove the temporary clamp on the donor tubing to permit blood flow into the Diversion Blood Sampling Arm pouch.CAUTION Do not touch the needle after removing the needle protector. Assure that the White Clamp below the pouch is closed prior to initiating phlebotomy.9. If using a needle safety device, follow the manufacturer's instructions to secure the device in place.10. Appropriately secure donor tubing to donor's arm.11. Position the diversion pouch with the notches up and the Tube Holder/Luer Adapter assembly (or port cap) down. When the level of blood in the pouch is approximately in linewith the notches, the diversion pouch is full. (Fig. 3a)NOTE: The approximate fill volume of the pouch at the notches is 35 mL.12. Permanently seal the tubing between the "Y" and the diversion pouch to maintain a closed system using an aluminum clip or a tube sealer approved for use with tubing connected to a donor. (Fig. 3b)13. To initiate blood flow into the collection bag, break the CLlKTIP between the "Y" and the primary bag.14. To avoid clot formation, collect samples as soon as possible from the diversion pouch as follows (Fig. 3b)CAUTION Do not collect donor test samples until the tubing between the "Y" and the diversion pouch is permanently sealed.a) Open the White Clamp on the tubing below the pouch to open the pathway for sampling.b) Position the diversion pouch with the notches up and the Tube Holder/Luer Adapter assembly down. Assure that any air in the pouch is at the top and will not enter theblood collection tubes.c) Insert vacuum blood collection tube firmly into the tube holder; when full, remove sample tube from holder. Repeat to collect additional samples.NOTE: The pouch may be removed after the donor test samples are collected. A second seal must be made between the diversion pouch and the permanent sealprior to removing the pouch.Insert Fig. 3a and 3b here. 15. Once samples are obtained, mix blood with anticoagulant in the primary bag and continue to mix at several intervals during collection. 16. Collect labeled volume of blood (+/–10%).17. When the desired amount of blood has been collected, seal the tubing or tighten the loose knot (white knot) prepared in step 2. Make a second seal between the first seal or knot andthe CLlKTIP below the "Y". Various methods may be used to seal tubing.18. Release pressure on the donor's arm and remove the needle. If using a needle safety device, follow the manufacturer's instructions to remove the needle. Sever the donor tubing between the two seals previously made below the CLlKTIP and "Y".CAUTION Discard the Diversion Blood Sampling Arm and phlebotomy needle/donor tubing according to institutional procedures.19. Immediately after collection, invert the bag several times to assure blood and anticoagulant are well mixed.20. Strip blood from the donor tubing into the bag, mix well, and allow tubing to refill. Seal on or near the X marks on the donor tubing to provide numbered aliquots of anticoagulated blood for testing.21. The time of addition of OPTISOL Solution may vary depending on the processing option selected. Add the solution under one of the following conditions after removal of plasma:a) Within 8 hours of whole blood collection, if components are prepared.b) Within 72 hours of collection if whole blood is refrigerated immediately following collection.22. Centrifuge the unit to separate red cells from plasma.23. Break the CLlKTIP of primary collection bag and transfer the plasma into the satellite bag. Clamp transfer tubing of satellite bag.24. Break the CLlKTIP of OPTlSOL Solution bag and drain contents into primary bag containing red blood cells. Seal tubing of primary bag in two places, and cut between sealsand separate from satellite bag(s).NOTE: For TERUFLEX double bags, seal OPTISOL Solution bag tubing in two places and cut between seals. Discard OPTISOL Solution container.25. Invert the red cell- OPTISOL mixture several times to insure the final AS-5 red cell product is well suspended.26. Store AS-5 Red Blood Cells between 1-6°C.27. Infuse AS-5 Red Blood Cells within 42 days of collection.For further processing, use standard component processing techniques.To open blister package, peel cover film back four fifths of its length. After opening, unused bags may be stored for 30 days by returning cover film to original position and sealing with tape to prevent possible loss of moisture.Insert Fig. 4 here. CAUTIONSThe packet of AGELESS contained in this package absorbs oxygen and generates heat on removal. Handle it with care. Dispose with packet in tray. Do not dispose with wastes containing volatile or flammable materials. Discard AGELESS packet without opening.N-BB-OP-A2(DB) 1TERUMO® MANUFACTURED BY: TERUMO CORPORATION 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO, JAPAN MADE IN JAPAN®: Registered Trademark Diversion Blood Sampling Arm and CLIKTIP are trademarks of TERUMO CORPORATION.© TERUMO CORPORATION 2003 03F10.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>53877-008-71</NDCCode>
<PackageDescription>18 BAG in 1 CASE (53877-008-71) > 1 KIT in 1 BAG * 70 mL in 1 BAG * 111 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0008-71</NDC11Code>
<ProductNDC>53877-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System With Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative</ProprietaryName>
<NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20100505</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN880217</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.1. Read these instructions carefully before use. 1.2. Rx ONLY. 1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion. 1.4. For the collection of 450 mL ±10% or 500 mL ±10% Whole Blood. 1.5. Integral Diversion Blood Sampling Arm is intended to divert and obtain donor samples for laboratory testing prior to collection of the Whole Blood unit. 1.6. For further processing, use standard component processing techniques.</IndicationAndUsage>
<Description>11.1. This blood bag system includes a 16 gauge × 1 1/2 inch (1.60 × 38 mm) needle with needle cover and either a 450mL or 500mL (nominal capacity 600mL) primary collection bag containing 63 mL or 70mL, respectively, Citrate Phosphate Dextrose (CPD) anticoagulant. The Double blood bag set has one integrally attached empty satellite bag and one satellite bag containing 100 mL or 111 mL, respectively, OPTISOL Red Cell Preservative Solution. The Triple blood bag set has one empty XT-612 5 day Platelet bag and one satellite bag containing 100 mL or 111 mL, respectively, OPTISOL Red Cell Preservative Solution. The Quadruple blood bag set has one integrally attached empty XT-612 5 day Platelet bag, one empty satellite bag, and one satellite bag containing 100 mL or 111 mL, respectively, OPTISOL Red Cell Preservative Solution. 11.2. Blood bag codes ending in A2 are supplied with Integral Diversion Blood Sampling Arm intended to divert and obtain donor samples for laboratory testing prior to collection of the Whole Blood unit. 11.3. Blood bag codes ending in A2 also include a DonorCare® Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4. The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5. The blood bag has no components made of natural rubber latex. 11.6. Tubing internal diameter (ID) nominal 3.0 mm. 11.7. Tubing outer diameter (OD) nominal 4.4 mm. 11.8. Donor tubing line maximum 16 segments available.</Description>
</NDC>
<NDC>
<NDCCode>12022-008-00</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (12022-008-00) / 81 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>12022-0008-00</NDC11Code>
<ProductNDC>12022-008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Glovers Dandruff Control Med., Floral</ProprietaryName>
<NonProprietaryName>Sulfur</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20011105</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>J. Strickland & Co.</LabelerName>
<SubstanceName>SULFUR</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20011105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Controls scalp itching and flaking due to dandruff.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50814-008-01</NDCCode>
<PackageDescription>.81 mL in 1 BAG (50814-008-01) </PackageDescription>
<NDC11Code>50814-0008-01</NDC11Code>
<ProductNDC>50814-008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antiseptic Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160701</StartMarketingDate>
<EndMarketingDate>20251231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>GFA Production (Xiamen) Co., Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160701</StartMarketingDatePackage>
<EndMarketingDatePackage>20251231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For handwashing to decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>77720-008-03</NDCCode>
<PackageDescription>20 POUCH in 1 BAG (77720-008-03) > 81 g in 1 POUCH</PackageDescription>
<NDC11Code>77720-0008-03</NDC11Code>
<ProductNDC>77720-008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizing Wipes</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200915</StartMarketingDate>
<EndMarketingDate>20200920</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Skaffles Group Limited Liability Company</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-09-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200915</StartMarketingDatePackage>
<EndMarketingDatePackage>20200920</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>10019-008-01</NDCCode>
<PackageDescription>1 PATCH in 1 POUCH (10019-008-01) / 3 d in 1 PATCH</PackageDescription>
<NDC11Code>10019-0008-01</NDC11Code>
<ProductNDC>10019-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Transderm Scop</ProprietaryName>
<NonProprietaryName>Scopolamine</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20161201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017874</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>SCOPOLAMINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/3d</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRANSDERM SCŌP is indicated in adults for the prevention of: 1 nausea and vomiting associated with motion sickness., 2 post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery.</IndicationAndUsage>
<Description>TRANSDERM SCŌP (scopolamine transdermal system) is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.3 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is. Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The TRANSDERM SCŌPtransdermal system is a circular, 0.2 mm thick, 2.5 cm2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film; (2) a drug layer of scopolamine, crospovidone, isopropyl palmitate, light mineral oil, and polyisobutylene; (3) an ethylene vinyl acetate copolymer membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, and scopolamine. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used. Cross section of the system.</Description>
</NDC>
<NDC>
<NDCCode>10019-008-04</NDCCode>
<PackageDescription>4 POUCH in 1 BOX (10019-008-04) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH</PackageDescription>
<NDC11Code>10019-0008-04</NDC11Code>
<ProductNDC>10019-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Transderm Scop</ProprietaryName>
<NonProprietaryName>Scopolamine</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20161201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017874</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>SCOPOLAMINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/3d</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRANSDERM SCŌP is indicated in adults for the prevention of: 1 nausea and vomiting associated with motion sickness., 2 post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery.</IndicationAndUsage>
<Description>TRANSDERM SCŌP (scopolamine transdermal system) is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.3 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is. Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The TRANSDERM SCŌPtransdermal system is a circular, 0.2 mm thick, 2.5 cm2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film; (2) a drug layer of scopolamine, crospovidone, isopropyl palmitate, light mineral oil, and polyisobutylene; (3) an ethylene vinyl acetate copolymer membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, and scopolamine. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used. Cross section of the system.</Description>
</NDC>
<NDC>
<NDCCode>10019-008-10</NDCCode>
<PackageDescription>10 POUCH in 1 BOX (10019-008-10) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH</PackageDescription>
<NDC11Code>10019-0008-10</NDC11Code>
<ProductNDC>10019-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Transderm Scop</ProprietaryName>
<NonProprietaryName>Scopolamine</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20161201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017874</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>SCOPOLAMINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/3d</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRANSDERM SCŌP is indicated in adults for the prevention of: 1 nausea and vomiting associated with motion sickness., 2 post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery.</IndicationAndUsage>
<Description>TRANSDERM SCŌP (scopolamine transdermal system) is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.3 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is. Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The TRANSDERM SCŌPtransdermal system is a circular, 0.2 mm thick, 2.5 cm2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film; (2) a drug layer of scopolamine, crospovidone, isopropyl palmitate, light mineral oil, and polyisobutylene; (3) an ethylene vinyl acetate copolymer membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, and scopolamine. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used. Cross section of the system.</Description>
</NDC>
<NDC>
<NDCCode>10019-008-24</NDCCode>
<PackageDescription>24 POUCH in 1 BOX (10019-008-24) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH</PackageDescription>
<NDC11Code>10019-0008-24</NDC11Code>
<ProductNDC>10019-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Transderm Scop</ProprietaryName>
<NonProprietaryName>Scopolamine</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20161201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017874</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>SCOPOLAMINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/3d</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRANSDERM SCŌP is indicated in adults for the prevention of: 1 nausea and vomiting associated with motion sickness., 2 post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery.</IndicationAndUsage>
<Description>TRANSDERM SCŌP (scopolamine transdermal system) is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.3 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is. Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The TRANSDERM SCŌPtransdermal system is a circular, 0.2 mm thick, 2.5 cm2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film; (2) a drug layer of scopolamine, crospovidone, isopropyl palmitate, light mineral oil, and polyisobutylene; (3) an ethylene vinyl acetate copolymer membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, and scopolamine. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used. Cross section of the system.</Description>
</NDC>
<NDC>
<NDCCode>10631-008-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10631-008-30) </PackageDescription>
<NDC11Code>10631-0008-30</NDC11Code>
<ProductNDC>10631-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kapspargo</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180315</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210428</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>KAPSPARGO Sprinkle is a beta1-adrenergic blocker indicated for the treatment of: Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) Angina Pectoris. (1.2) Heart Failure, to reduce the risk of cardiovascular mortality and heart-failure hospitalizations in patients with heart failure. (1.3).</IndicationAndUsage>
<Description>Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release capsules. Metoprolol succinate extended-release capsules have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The extended-release capsules comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The extended-release capsules contain 10.24 mg, 20.48 mg, 40.96 mg, and 81.92 mg of metoprolol free base, present as 23.75 mg, 47.5 mg, 95 mg, and 190 mg of metoprolol succinate and are equivalent to 25 mg, 50 mg, 100 mg, and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate, USP is a white to off-white powder with a molecular weight of 652.82. It is freely soluble in water, soluble in methanol, sparingly soluble in alcohol, slightly soluble in isopropyl alcohol. Inactive ingredients: ethyl cellulose, hypromellose, polyethylene glycol 400, polyethylene glycol 6000, sugar spheres (corn starch and sucrose), talc and triethyl citrate. The capsule shell and imprinting ink has the following composition: ferric oxide yellow (25 mg, 50 mg and 200 mg), ferrosoferric oxide, gelatin, potassium hydroxide, propylene glycol, shellac and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>63304-008-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-008-30) </PackageDescription>
<NDC11Code>63304-0008-30</NDC11Code>
<ProductNDC>63304-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180207</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210428</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries Inc.</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2018-02-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol succinate extended-release capsules are beta1-selective adrenoceptor blocking agent indicated for the treatment of: : 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) , 2 Angina Pectoris. (1.2) , 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart-failure hospitalization in patients with heart failure. (1.3).</IndicationAndUsage>
<Description>Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release capsules. Metoprolol succinate extended-release capsules have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The extended-release capsules comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The extended-release capsules contain 10.24 mg, 20.48 mg, 40.96 mg, and 81.92 mg of metoprolol free base, present as 23.75 mg, 47.5 mg, 95 mg, and 190 mg of metoprolol succinate and are equivalent to 25 mg, 50 mg, 100 mg, and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate, USP is a white to off-white powder with a molecular weight of 652.82. It is freely soluble in water, soluble in methanol, sparingly soluble in alcohol, slightly soluble in isopropyl alcohol. Inactive ingredients: ethyl cellulose, hypromellose, polyethylene glycol 400, polyethylene glycol 6000, sugar spheres (corn starch and sucrose), talc and triethyl citrate. The capsule shell and imprinting ink has the following composition: ferric oxide yellow (25 mg, 50 mg and 200 mg), ferrosoferric oxide, gelatin, potassium hydroxide, propylene glycol, shellac and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71635-090-02</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (71635-090-02) > 81 g in 1 BOTTLE, PLASTIC (71635-090-01)</PackageDescription>
<NDC11Code>71635-0090-02</NDC11Code>
<ProductNDC>71635-090</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mulbit</ProprietaryName>
<ProprietaryNameSuffix>Medist</ProprietaryNameSuffix>
<NonProprietaryName>Niacinamide, Adenosine</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171001</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>First Cosmetic Co., Ltd</LabelerName>
<SubstanceName>NIACINAMIDE; ADENOSINE</SubstanceName>
<StrengthNumber>.08; .008</StrengthNumber>
<StrengthUnit>g/81g; g/81g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses: MULBIT MEDIST is a tablet that contains fruit ingredients of lemon and strawberry and vitamin C, B2 and B3. The carbonic bubbles created while the tablet is being dissolved in water eliminate wastes from your skin, stimulating the skin and they cleanse and brighten your skin. The fruit ingredients of lemon and strawberry and other ingredients such as vitamin, sucrose, trehalose and adenosine supply nutrients to your skin and moisturize, creating a thin moisturizing coat which makes your skin even moister.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>53877-001-01</NDCCode>
<PackageDescription>30 BAG in 1 CASE (53877-001-01) > 35 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0001-01</NDC11Code>
<ProductNDC>53877-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName>
<NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20091118</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN820528</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<SubstanceName>ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
<StrengthNumber>.275; 2.99; 31.9; 2.22; 26.3</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the collection of 250 mL of Whole Blood. Revised 2015-12 N-BB-A 3. FULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 7, 8, 9, 10, 12, 13, 14, 15 and 17].1. INDICATIONS AND USAGE1.1. Read these instructions carefully before use. 1.2. Rx ONLY.1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4. For the collection of 250 mL ±10% Whole Blood: 1.4.1. From elderly, pediatric, or smaller autologous donors who may not tolerate larger blood collections. 1.4.2. For blood collections as directed by a patient's physician.1.5. NOTE: Production of Platelets and Plasma is not intended with this product.</IndicationAndUsage>
<Description>11. DESCRIPTION. 11.1. This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and a 250 mL (nominal capacity 300 mL) collection bag containing 35 mL Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant. 11.2. The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.3. The blood bag has no components made of natural rubber latex. 11.4. Tubing internal diameter (ID) nominal 3.0 mm. 11.5. Tubing outer diameter (OD) nominal 4.4 mm. 11.6. Donor tubing line maximum 12 segments available.</Description>
</NDC>
<NDC>
<NDCCode>53877-001-02</NDCCode>
<PackageDescription>30 BAG in 1 CASE (53877-001-02) > 63 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0001-02</NDC11Code>
<ProductNDC>53877-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName>
<NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20091210</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN820528</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<SubstanceName>ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
<StrengthNumber>.275; 2.99; 31.9; 2.22; 26.3</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Revised 2011-11 N-BB-CA-A 5BB89X505+5FULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 7, 8, 9, 10, 12, 13, 14, 15 and 17].1. INDICATIONS AND USAGE1.1. Read these instructions carefully before use.1.2. Rx ONLY1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4. For the collection of 450 mL +/- 10% Whole Blood.1.5. For further processing, use standard component processing techniques.</IndicationAndUsage>
<Description>11. DESCRIPTION. 11.1. This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and a 450 mL (nominal capacity 600 mL) primary collection bag containing 63 mL Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant. The Double blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL). The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2. The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.3. The blood bag has no components made of natural rubber latex. 11.4. Tubing internal diameter (ID) nominal 3.0 mm. 11.5. Tubing outer diameter (OD) nominal 4.4 mm. 11.6. Donor tubing line maximum 19 segments available.</Description>
</NDC>
<NDC>
<NDCCode>53877-001-03</NDCCode>
<PackageDescription>60 BAG in 1 CASE (53877-001-03) > 63 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0001-03</NDC11Code>
<ProductNDC>53877-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName>
<NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20091210</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN820528</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<SubstanceName>ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
<StrengthNumber>.275; 2.99; 31.9; 2.22; 26.3</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Revised 2011-11 N-BB-CA-A 5BB89X505+5FULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 7, 8, 9, 10, 12, 13, 14, 15 and 17].1. INDICATIONS AND USAGE1.1. Read these instructions carefully before use.1.2. Rx ONLY1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4. For the collection of 450 mL +/- 10% Whole Blood.1.5. For further processing, use standard component processing techniques.</IndicationAndUsage>
<Description>11. DESCRIPTION. 11.1. This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and a 450 mL (nominal capacity 600 mL) primary collection bag containing 63 mL Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant. The Double blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL). The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2. The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.3. The blood bag has no components made of natural rubber latex. 11.4. Tubing internal diameter (ID) nominal 3.0 mm. 11.5. Tubing outer diameter (OD) nominal 4.4 mm. 11.6. Donor tubing line maximum 19 segments available.</Description>
</NDC>
<NDC>
<NDCCode>53877-001-04</NDCCode>
<PackageDescription>48 BAG in 1 CASE (53877-001-04) > 63 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0001-04</NDC11Code>
<ProductNDC>53877-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName>
<NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20091214</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN820528</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<SubstanceName>ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
<StrengthNumber>.275; 2.99; 31.9; 2.22; 26.3</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 7, 8, 9, 10, 12, 13, 14, 15 and 17].1. INDICATIONS AND USAGE1.1. Read these instructions carefully before use.1.2. Rx ONLY.1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4. For the collection of 450 mL ±10% or 500 mL ±10% Whole Blood.1.5. Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit.1.6. For further processing, use standard component processing techniques.</IndicationAndUsage>
<Description>11. DESCRIPTION / PRODUCT SPECIFICATIONS. 11.1. This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and either a 450 mL or 500 mL (nominal capacity 600 mL) primary collection bag containing 63 mL or 70 mL, respectively, Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant, The Double blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL). The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). The Quadruple blood bag set has two integrally attached empty satellite bags (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2. Blood bag codes ending in A4 are supplied with Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit. 11.3. Blood bag codes ending in A3 also include a DonorCare Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4. The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5. The blood bag has no components made of natural rubber latex. 11.6. Tubing internal diameter (ID) nominal 3.0 mm. 11.7. Tubing outer diameter (OD) nominal 4.4 mm. 11.8. Donor tubing line maximum 16 segments available.</Description>
</NDC>
<NDC>
<NDCCode>53877-001-05</NDCCode>
<PackageDescription>30 BAG in 1 CASE (53877-001-05) > 63 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0001-05</NDC11Code>
<ProductNDC>53877-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName>
<NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20091214</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN820528</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<SubstanceName>ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
<StrengthNumber>.275; 2.99; 31.9; 2.22; 26.3</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 7, 8, 9, 10, 12, 13, 14, 15 and 17].1. INDICATIONS AND USAGE1.1. Read these instructions carefully before use.1.2. Rx ONLY.1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4. For the collection of 450 mL ±10% or 500 mL ±10% Whole Blood.1.5. Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit.1.6. For further processing, use standard component processing techniques.</IndicationAndUsage>
<Description>11. DESCRIPTION / PRODUCT SPECIFICATIONS. 11.1. This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and either a 450 mL or 500 mL (nominal capacity 600 mL) primary collection bag containing 63 mL or 70 mL, respectively, Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant, The Double blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL). The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). The Quadruple blood bag set has two integrally attached empty satellite bags (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2. Blood bag codes ending in A4 are supplied with Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit. 11.3. Blood bag codes ending in A3 also include a DonorCare Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4. The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5. The blood bag has no components made of natural rubber latex. 11.6. Tubing internal diameter (ID) nominal 3.0 mm. 11.7. Tubing outer diameter (OD) nominal 4.4 mm. 11.8. Donor tubing line maximum 16 segments available.</Description>
</NDC>
<NDC>
<NDCCode>53877-001-06</NDCCode>
<PackageDescription>36 BAG in 1 CASE (53877-001-06) > 70 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0001-06</NDC11Code>
<ProductNDC>53877-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName>
<NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20091214</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN820528</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<SubstanceName>ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
<StrengthNumber>.275; 2.99; 31.9; 2.22; 26.3</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 7, 8, 9, 10, 12, 13, 14, 15 and 17].1. INDICATIONS AND USAGE1.1. Read these instructions carefully before use.1.2. Rx ONLY.1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4. For the collection of 450 mL ±10% or 500 mL ±10% Whole Blood.1.5. Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit.1.6. For further processing, use standard component processing techniques.</IndicationAndUsage>
<Description>11. DESCRIPTION / PRODUCT SPECIFICATIONS. 11.1. This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and either a 450 mL or 500 mL (nominal capacity 600 mL) primary collection bag containing 63 mL or 70 mL, respectively, Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant, The Double blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL). The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). The Quadruple blood bag set has two integrally attached empty satellite bags (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2. Blood bag codes ending in A4 are supplied with Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit. 11.3. Blood bag codes ending in A3 also include a DonorCare Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4. The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5. The blood bag has no components made of natural rubber latex. 11.6. Tubing internal diameter (ID) nominal 3.0 mm. 11.7. Tubing outer diameter (OD) nominal 4.4 mm. 11.8. Donor tubing line maximum 16 segments available.</Description>
</NDC>
<NDC>
<NDCCode>53877-001-07</NDCCode>
<PackageDescription>30 BAG in 1 CASE (53877-001-07) > 70 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0001-07</NDC11Code>
<ProductNDC>53877-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName>
<NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20091214</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN820528</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<SubstanceName>ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
<StrengthNumber>.275; 2.99; 31.9; 2.22; 26.3</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 7, 8, 9, 10, 12, 13, 14, 15 and 17].1. INDICATIONS AND USAGE1.1. Read these instructions carefully before use.1.2. Rx ONLY.1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4. For the collection of 450 mL ±10% or 500 mL ±10% Whole Blood.1.5. Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit.1.6. For further processing, use standard component processing techniques.</IndicationAndUsage>
<Description>11. DESCRIPTION / PRODUCT SPECIFICATIONS. 11.1. This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and either a 450 mL or 500 mL (nominal capacity 600 mL) primary collection bag containing 63 mL or 70 mL, respectively, Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant, The Double blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL). The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). The Quadruple blood bag set has two integrally attached empty satellite bags (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2. Blood bag codes ending in A4 are supplied with Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit. 11.3. Blood bag codes ending in A3 also include a DonorCare Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4. The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5. The blood bag has no components made of natural rubber latex. 11.6. Tubing internal diameter (ID) nominal 3.0 mm. 11.7. Tubing outer diameter (OD) nominal 4.4 mm. 11.8. Donor tubing line maximum 16 segments available.</Description>
</NDC>
<NDC>
<NDCCode>53877-001-08</NDCCode>
<PackageDescription>24 BAG in 1 CASE (53877-001-08) > 70 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0001-08</NDC11Code>
<ProductNDC>53877-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName>
<NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20091214</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN820528</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<SubstanceName>ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
<StrengthNumber>.275; 2.99; 31.9; 2.22; 26.3</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 7, 8, 9, 10, 12, 13, 14, 15 and 17].1. INDICATIONS AND USAGE1.1. Read these instructions carefully before use.1.2. Rx ONLY.1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4. For the collection of 450 mL ±10% or 500 mL ±10% Whole Blood.1.5. Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit.1.6. For further processing, use standard component processing techniques.</IndicationAndUsage>
<Description>11. DESCRIPTION / PRODUCT SPECIFICATIONS. 11.1. This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and either a 450 mL or 500 mL (nominal capacity 600 mL) primary collection bag containing 63 mL or 70 mL, respectively, Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant, The Double blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL). The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). The Quadruple blood bag set has two integrally attached empty satellite bags (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2. Blood bag codes ending in A4 are supplied with Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit. 11.3. Blood bag codes ending in A3 also include a DonorCare Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4. The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5. The blood bag has no components made of natural rubber latex. 11.6. Tubing internal diameter (ID) nominal 3.0 mm. 11.7. Tubing outer diameter (OD) nominal 4.4 mm. 11.8. Donor tubing line maximum 16 segments available.</Description>
</NDC>
<NDC>
<NDCCode>53877-001-09</NDCCode>
<PackageDescription>24 BAG in 1 CASE (53877-001-09) > 63 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0001-09</NDC11Code>
<ProductNDC>53877-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName>
<NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20091214</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN820528</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<SubstanceName>ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
<StrengthNumber>.275; 2.99; 31.9; 2.22; 26.3</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 7, 8, 9, 10, 12, 13, 14, 15 and 17].1. INDICATIONS AND USAGE1.1. Read these instructions carefully before use.1.2. Rx ONLY.1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4. For the collection of 450 mL ±10% or 500 mL ±10% Whole Blood.1.5. Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit.1.6. For further processing, use standard component processing techniques.</IndicationAndUsage>
<Description>11. DESCRIPTION / PRODUCT SPECIFICATIONS. 11.1. This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and either a 450 mL or 500 mL (nominal capacity 600 mL) primary collection bag containing 63 mL or 70 mL, respectively, Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant, The Double blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL). The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). The Quadruple blood bag set has two integrally attached empty satellite bags (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2. Blood bag codes ending in A4 are supplied with Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit. 11.3. Blood bag codes ending in A3 also include a DonorCare Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4. The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5. The blood bag has no components made of natural rubber latex. 11.6. Tubing internal diameter (ID) nominal 3.0 mm. 11.7. Tubing outer diameter (OD) nominal 4.4 mm. 11.8. Donor tubing line maximum 16 segments available.</Description>
</NDC>
<NDC>
<NDCCode>53877-001-10</NDCCode>
<PackageDescription>36 BAG in 1 CASE (53877-001-10) > 63 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0001-10</NDC11Code>
<ProductNDC>53877-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName>
<NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20091214</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN820528</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<SubstanceName>ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
<StrengthNumber>.275; 2.99; 31.9; 2.22; 26.3</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 7, 8, 9, 10, 12, 13, 14, 15 and 17].1. INDICATIONS AND USAGE1.1. Read these instructions carefully before use.1.2. Rx ONLY.1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4. For the collection of 450 mL ±10% or 500 mL ±10% Whole Blood.1.5. Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit.1.6. For further processing, use standard component processing techniques.</IndicationAndUsage>
<Description>11. DESCRIPTION / PRODUCT SPECIFICATIONS. 11.1. This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and either a 450 mL or 500 mL (nominal capacity 600 mL) primary collection bag containing 63 mL or 70 mL, respectively, Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant, The Double blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL). The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). The Quadruple blood bag set has two integrally attached empty satellite bags (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2. Blood bag codes ending in A4 are supplied with Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit. 11.3. Blood bag codes ending in A3 also include a DonorCare Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4. The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5. The blood bag has no components made of natural rubber latex. 11.6. Tubing internal diameter (ID) nominal 3.0 mm. 11.7. Tubing outer diameter (OD) nominal 4.4 mm. 11.8. Donor tubing line maximum 16 segments available.</Description>
</NDC>
<NDC>
<NDCCode>53877-001-11</NDCCode>
<PackageDescription>30 BAG in 1 CASE (53877-001-11) > 63 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0001-11</NDC11Code>
<ProductNDC>53877-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName>
<NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120522</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN820528</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<SubstanceName>ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
<StrengthNumber>.275; 2.99; 31.9; 2.22; 26.3</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Issued 2011-11 N-BB-CA-A-DB(2)BB89X404+2TERUFLEX BLOOD BAG SYSTEM with Diversion Blood Sampling ArmCPDA-1 SOLUTIONFor the collection of 450 mL and 500 mL of Whole BloodFULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 8, 9, 10, 12, 13, 14, 15 and 17].1. INDICATIONS AND USAGE1.1. Read these instructions carefully before use.1.2. Rx ONLY1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4. For the collection of 450 mL +/- 10% and 500 mL +/- 10% Whole Blood.1.5. Integral Diversion Blood Sampling Arm is intended to divert and obtain donor samples for laboratory testing prior to collection of the whole blood unit.1.6. For further processing, use standard component processing techniques.</IndicationAndUsage>
<Description>11. DESCRIPTION/PRODUCT SPECIFICATIONS. 11.1. This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and either 450 mL or 500 mL (nominal capacity 600 mL) primary collection bag containing 63 mL or 70 mL, respectively, Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant. The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). The Quadruple blood bag set has two integrally attached empty satellite bags (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2. Blood bag codes ending in A2 are supplied with Integral Diversion Blood Sampling Arm intended to divert and obtain donor samples for laboratory testing prior to collection of the Whole Blood unit. 11.3. Blood bag codes ending in A2 also include a DonorCare Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4. The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5. The blood bag has no components made of natural rubber latex. 11.6. Tubing internal diameter (ID) nominal 3.0 mm. 11.7. Tubing outer diameter (OD) nominal 4.4 mm. 11.8. Donor tubing line maximum 16 segments available.</Description>
</NDC>
<NDC>
<NDCCode>53877-001-12</NDCCode>
<PackageDescription>24 BAG in 1 CASE (53877-001-12) > 63 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0001-12</NDC11Code>
<ProductNDC>53877-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName>
<NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120522</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN820528</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<SubstanceName>ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
<StrengthNumber>.275; 2.99; 31.9; 2.22; 26.3</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Issued 2011-11 N-BB-CA-A-DB(2)BB89X404+2TERUFLEX BLOOD BAG SYSTEM with Diversion Blood Sampling ArmCPDA-1 SOLUTIONFor the collection of 450 mL and 500 mL of Whole BloodFULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 8, 9, 10, 12, 13, 14, 15 and 17].1. INDICATIONS AND USAGE1.1. Read these instructions carefully before use.1.2. Rx ONLY1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4. For the collection of 450 mL +/- 10% and 500 mL +/- 10% Whole Blood.1.5. Integral Diversion Blood Sampling Arm is intended to divert and obtain donor samples for laboratory testing prior to collection of the whole blood unit.1.6. For further processing, use standard component processing techniques.</IndicationAndUsage>
<Description>11. DESCRIPTION/PRODUCT SPECIFICATIONS. 11.1. This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and either 450 mL or 500 mL (nominal capacity 600 mL) primary collection bag containing 63 mL or 70 mL, respectively, Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant. The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). The Quadruple blood bag set has two integrally attached empty satellite bags (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2. Blood bag codes ending in A2 are supplied with Integral Diversion Blood Sampling Arm intended to divert and obtain donor samples for laboratory testing prior to collection of the Whole Blood unit. 11.3. Blood bag codes ending in A2 also include a DonorCare Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4. The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5. The blood bag has no components made of natural rubber latex. 11.6. Tubing internal diameter (ID) nominal 3.0 mm. 11.7. Tubing outer diameter (OD) nominal 4.4 mm. 11.8. Donor tubing line maximum 16 segments available.</Description>
</NDC>
<NDC>
<NDCCode>53877-001-13</NDCCode>
<PackageDescription>30 BAG in 1 CASE (53877-001-13) > 70 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0001-13</NDC11Code>
<ProductNDC>53877-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName>
<NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120522</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN820528</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<SubstanceName>ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
<StrengthNumber>.275; 2.99; 31.9; 2.22; 26.3</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Issued 2011-11 N-BB-CA-A-DB(2)BB89X404+2TERUFLEX BLOOD BAG SYSTEM with Diversion Blood Sampling ArmCPDA-1 SOLUTIONFor the collection of 450 mL and 500 mL of Whole BloodFULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 8, 9, 10, 12, 13, 14, 15 and 17].1. INDICATIONS AND USAGE1.1. Read these instructions carefully before use.1.2. Rx ONLY1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4. For the collection of 450 mL +/- 10% and 500 mL +/- 10% Whole Blood.1.5. Integral Diversion Blood Sampling Arm is intended to divert and obtain donor samples for laboratory testing prior to collection of the whole blood unit.1.6. For further processing, use standard component processing techniques.</IndicationAndUsage>
<Description>11. DESCRIPTION/PRODUCT SPECIFICATIONS. 11.1. This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and either 450 mL or 500 mL (nominal capacity 600 mL) primary collection bag containing 63 mL or 70 mL, respectively, Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant. The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). The Quadruple blood bag set has two integrally attached empty satellite bags (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2. Blood bag codes ending in A2 are supplied with Integral Diversion Blood Sampling Arm intended to divert and obtain donor samples for laboratory testing prior to collection of the Whole Blood unit. 11.3. Blood bag codes ending in A2 also include a DonorCare Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4. The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5. The blood bag has no components made of natural rubber latex. 11.6. Tubing internal diameter (ID) nominal 3.0 mm. 11.7. Tubing outer diameter (OD) nominal 4.4 mm. 11.8. Donor tubing line maximum 16 segments available.</Description>
</NDC>
<NDC>
<NDCCode>53877-001-14</NDCCode>
<PackageDescription>24 BAG in 1 CASE (53877-001-14) > 70 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0001-14</NDC11Code>
<ProductNDC>53877-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</ProprietaryName>
<NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120522</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN820528</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<SubstanceName>ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
<StrengthNumber>.275; 2.99; 31.9; 2.22; 26.3</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Issued 2011-11 N-BB-CA-A-DB(2)BB89X404+2TERUFLEX BLOOD BAG SYSTEM with Diversion Blood Sampling ArmCPDA-1 SOLUTIONFor the collection of 450 mL and 500 mL of Whole BloodFULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 8, 9, 10, 12, 13, 14, 15 and 17].1. INDICATIONS AND USAGE1.1. Read these instructions carefully before use.1.2. Rx ONLY1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4. For the collection of 450 mL +/- 10% and 500 mL +/- 10% Whole Blood.1.5. Integral Diversion Blood Sampling Arm is intended to divert and obtain donor samples for laboratory testing prior to collection of the whole blood unit.1.6. For further processing, use standard component processing techniques.</IndicationAndUsage>
<Description>11. DESCRIPTION/PRODUCT SPECIFICATIONS. 11.1. This blood bag system includes a 16 gauge x 1 1/2 inch (1.60 x 38 mm) needle with needle cover and either 450 mL or 500 mL (nominal capacity 600 mL) primary collection bag containing 63 mL or 70 mL, respectively, Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant. The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). The Quadruple blood bag set has two integrally attached empty satellite bags (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2. Blood bag codes ending in A2 are supplied with Integral Diversion Blood Sampling Arm intended to divert and obtain donor samples for laboratory testing prior to collection of the Whole Blood unit. 11.3. Blood bag codes ending in A2 also include a DonorCare Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4. The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5. The blood bag has no components made of natural rubber latex. 11.6. Tubing internal diameter (ID) nominal 3.0 mm. 11.7. Tubing outer diameter (OD) nominal 4.4 mm. 11.8. Donor tubing line maximum 16 segments available.</Description>
</NDC>
<NDC>
<NDCCode>53877-005-01</NDCCode>
<PackageDescription>30 BAG in 1 CASE (53877-005-01) / 1 KIT in 1 BAG * 35 mL in 1 BAG * 56 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0005-01</NDC11Code>
<ProductNDC>53877-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol Red Cell Preservative</ProprietaryName>
<NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20091215</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN880217</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-02-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>53877-005-21</NDCCode>
<PackageDescription>24 BAG in 1 CASE (53877-005-21) > 1 KIT in 1 BAG * 63 mL in 1 BAG * 100 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0005-21</NDC11Code>
<ProductNDC>53877-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol Red Cell Preservative</ProprietaryName>
<NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20100113</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN880217</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Revised 8/96TERUFLEX® BLOOD BAG SYSTEMCPD/OPTISOL® SOLUTIONRead these instructions before use.INSTRUCTIONS FOR BLOOD COLLECTION: Use aseptic technique1. Confirm that all numbered tubing of each blood bag unit contains segment numbers.2. Make a loose knot in the donor tubing approximately 10 cm from needle unless alternate methods are used to seal tubing.3. Clamp donor tubing.4. Suspend primary bag as far as possible below the donor's arm.5. Apply blood pressure cuff or tourniquiet to donor's arm. Disinfect site of phlebotomy. If blood pressure cuff is used, inflate cuff to 60 mmHg.6. Remove needle protector and perform phlebotomy. Remove clamp to permit blood flow into primary bag. CAUTION Do not touch needle after removing the needle protector.7. Appropriately secure donor tubing to donor's arm.8. MIX BLOOD WITH ANTICOAGULANT AT SEVERAL INTERVALS DURING COLLECTION.9. Collect labeled volume of blood (+/- 10%).10. Tighten knot firmly after collection. Clamp between knot and needle. Sever donor tubing between knot and clamp. Collect blood samples.11. Reapply clamp to donor tubing; release pressure on donor's arm and remove needle. Seal donor tubing. CAUTION Discard tubing/phlebotomy needle unit according to institutional procedures.12. Immediately after collection, invert bag several times to assure blood and anticoagulant are well mixed.13. Strip blood from donor tubing into bag, mix well, and allow tubing to refill. Seal on or near X marks on donor tubing to provide numbered aliquots of anticoagulated blood for testing.14. Centrifuge unit to separate red cells from plasma.15.The time of addition of OPTISOL Solution may vary depending on the processing option selected. Add solution under one of the following conditions.a) After removal of plasma from freshly collected blood.b) Within 8 hours of blood collection if components are prepared.c) Within 72 hours of collection if blood is refrigerated immediately following collection.16. Snap CLIKTIP (incline closure device) of primary collection bag and transfer plasma into satellite bag. Clamp transfer tubing of satellite bag.17. Snap CLIKTIP of OPTISOL Solution bag and drain contents into primary bag containing red blood cells. Seal tubing of primary bag in two places, and cut between seals and separate from satellite bag(s).NOTE: For TERUFLEX double bags, seal OPTISOL Solution bag tubing in two places, and cut between seals. Discard OPTISOL Solution container.18. Invert the red cell- OPTISOL mixture several times to insure that the final AS-5 red cell product is well suspended.19. Store AS-5 Red Blood Cells between 1-6oC.20. Infuse AS-5 Red Blood Cells within 42 days of collection.For further processing, use standard component processing techniques.To open the blister package, peel the cover film back 4/5 of its length.After opening, unused bags may be stored for 30 days by returning cover film to original position and sealing with tape to prevent possible loss of moisture. CAUTIONS THE PACKET OF AGELESS CONTAINED IN THIS PACKAGE ABSORBS OXYGEN AND GENERATES HEAT ON REMOVAL AND SHOULD BE HANDLED WITH CARE. DISPOSE WITH PACKET IN TRAY. DO NOT DISPOSE WITH WASTES CONTAINING VOLATILE OR FLAMMABLE MATERIALS. DISCARD AGELESS PACKET WITHOUT OPENING.TERUMO CORPORATION44-1, 2-chome, Hatagaya, Shibuya-Ku, Tokyo, Japan®: Registered TrademarkN-BB-OP-A (4).</IndicationAndUsage>
</NDC>
</NDCList>