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

NDC 53877-009 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 Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 53877-009?
  4. Teruflex Blood Bag System With Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes

Product Information

NDC 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: [1]
Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Administration Route(s): [4]
  • Intravenous - Administration within or into a vein or veins.
  • Intravenous - Administration within or into a vein or veins.
    • Labeler Name: [5]
    Terumo Corporation
    Labeler Code:
    53877
    Product Label ID:
    0becb391-9488-485a-9a7d-eb1da2a51e63
    FDA Application Number: [6]
    BN880217
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    05-05-2010
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 53877-009-31

    Package Description: 24 BAG in 1 CASE / 1 KIT in 1 BAG * 63 mL in 1 BAG * 100 mL in 1 BAG

    NDC 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 Details

    What is NDC 53877-009?

    The NDC code 53877-009 is assigned by the FDA to the product Teruflex Blood Bag System With Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative which is a human prescription drug product labeled by Terumo Corporation. The generic name of Teruflex Blood Bag System With Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative is anticoagulant citrate phosphate dextrose (cpd) and as-5 red cell preservative. The product's dosage form is kit and is administered via intravenous form. The product is distributed in 2 packages with assigned NDC codes 53877-009-31 24 bag in 1 case / 1 kit in 1 bag * 63 ml in 1 bag * 100 ml in 1 bag, 53877-009-41 24 bag in 1 case / 1 kit in 1 bag * 70 ml in 1 bag * 111 ml in 1 bag. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Teruflex Blood Bag System With Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative?

    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

    Which are Teruflex Blood Bag System With Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Teruflex Blood Bag System With Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

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    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".