NDC 53877-005 Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol Red Cell Preservative

Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative

NDC Product Code 53877-005

NDC CODE: 53877-005

Proprietary Name: Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol Red Cell Preservative What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative 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.

NDC Code Structure

  • 53877 - Terumo Corporation
    • 53877-005 - Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol Red Cell Preservative

NDC 53877-005-01

Package Description: 30 BAG in 1 CASE > 1 KIT in 1 BAG * 35 mL in 1 BAG * 56 mL in 1 BAG

NDC 53877-005-21

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

NDC Product Information

Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol Red Cell Preservative with NDC 53877-005 is a a human prescription drug product labeled by Terumo Corporation. The generic name of Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol 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.

Labeler Name: Terumo Corporation

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Prescription Drug 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.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • WATER (UNII: 059QF0KO0R)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intravenous - Administration within or into a vein or veins.
  • Intravenous - Administration within or into a vein or veins.

Product Labeler Information

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

Labeler Name: Terumo Corporation
Labeler Code: 53877
FDA Application Number: BN880217 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.

Marketing Category: NDA - A product marketed under an approved New Drug Application. 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.

Start Marketing Date: 01-13-2010 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 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.

Exclude Flag: N - NO 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".

* Please review the disclaimer below.

Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol Red Cell Preservative Product Label Images

Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol Red Cell Preservative Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Indications & Usage

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)

* Please review the disclaimer below.