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  5. NDC Package Code: 53877-009-41 Teruflex Blood Bag System With Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative

NDC Package 53877-009-41 Teruflex Blood Bag System With Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative

Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative Kit - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
53877-009-41
Package Description:
24 BAG in 1 CASE / 1 KIT in 1 BAG * 70 mL in 1 BAG * 111 mL in 1 BAG
Product Code:
53877-009
Proprietary Name:
Teruflex Blood Bag System With Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative
Non-Proprietary Name:
Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative
Usage Information:
Issued 8/96 TERUFLEX® BLOOD BAG SYSTEM With Blood Sampling Arm® CPD/OPTISOL® SOLUTIONRead these instructions carefully before use. INSTRUCTIONS FOR BLOOD COLLECTION: Use aseptic techniqueMaterials Needed: VENOJECT® ll Tube Holder (code P-1316R) VENOJECT® ll Multi-Sample Luer Adapter (code MN *2000) VENOJECT® ll Plastic Blood Collection Tubes (or equivalent glass or plastic evacuated blood collection tube)1. Confirm that all numbered tubing of each blood bag unit contains segment numbers.2. Make a loose knot in donor tubing below "Y" 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 tourniquet to donor's arm. Disinfect site of phlebotomy. If blood pressure cuff is used, inflate cuff to approximately 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 "Y". Sever donor tubing between the knot and clamp. Alternate methods may be used to seal tubing.CAUTION Do not use the dielectric tube sealer while the needle is connected to the donor's body.Anytime before Step #13 below, sever donor tubing between the two seals.Collect blood samples as follows:a) Connect VENOJECT II Multi-Sample Luer Adapter to VENOJECT II Tube Holder (Fig. 1).b) Remove covers and connect multi-sample luer adapter to female luer at end of donor sampling tubing (Fig. 2).c) Snap CLIKTIP in donor sampling tubing to open blood pathway.Insert Fig. 1 hereInsert Fig. 2 hered) Insert blood collection tube (VENOJECT II or equivalent) firmly into VENOJECT II Tube Holder : when full, remove sample tube from holder. Repeat to collect additional samples.11. Reapply clamp to donor tubing between phlebotomy needle and "Y"; release pressure on donor's arm and remove needle.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 the 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. The time of addition of OPTISOL Solution may vary depending on the processing option selected. Add the 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.15. Centrifuge the unit to separate red cells from plasma.16. Snap CLlKTIP (inline closure device) of primary collection bag and transfer plasma into satellite bag. Clamp transfer tubing of satellite bag.17. Snap 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 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 the final AS-5 red cell product is well suspended.19. Store AS-5 Red Blood Cells between 1-6°C.20. 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. 3 hereCAUTIONS•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® TERUMO CORPORATION 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO, JAPAN ®: Registered Trademark N-BB-OP-A(SP) 3
11-Digit NDC Billing Format:
53877000941
Product Type:
Human Prescription Drug
Labeler Name:
Terumo Corporation
Dosage Form:
Kit - A packaged collection of related material.
Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
  • Intravenous - Administration within or into a vein or veins.
    • Sample Package:
    No
    FDA Application Number:
    BN880217
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    05-05-2010
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    53877-009-3124 BAG in 1 CASE / 1 KIT in 1 BAG * 63 mL in 1 BAG * 100 mL in 1 BAG

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 53877-009-41?

    The NDC Packaged Code 53877-009-41 is assigned to a package of 24 bag in 1 case / 1 kit in 1 bag * 70 ml in 1 bag * 111 ml in 1 bag of Teruflex Blood Bag System With Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative, a human prescription drug labeled by Terumo Corporation. The product's dosage form is kit and is administered via intravenous form.

    Is NDC 53877-009 included in the NDC Directory?

    Yes, Teruflex Blood Bag System With Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative with product code 53877-009 is active and included in the NDC Directory. The product was first marketed by Terumo Corporation on May 05, 2010 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 53877-009-41?

    The 11-digit format is 53877000941. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-253877-009-415-4-253877-0009-41