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

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Teruflex Blood Bag System With Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative is issued 8/96 TERUFLEX® BLOOD BAG SYSTEM With Blood Sampling Arm® CPD/OPTISOL® SOLUTIONRead these instructions carefully before use. Marketed by Terumo Corporation, this product is identified by NDC 53877-009 and is authorized under FDA application BN880217.

Identification & Billing

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
11-Digit Billing Format
53877000941

Clinical Specifications

Proprietary Name
Teruflex Blood Bag System With Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative
Dosage Form
-
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

Regulatory & Marketing

Labeler Name
Terumo Corporation
FDA Application #
BN880217
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-05-2010
Listing Expiration
12-31-2024
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (53877-009). Click a package code to view its specific billing and regulatory data.

53877-009-31
24 BAG in 1 CASE / 1 KIT in 1 BAG * 63 mL in 1 BAG * 100 mL in 1 BAG

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 53877-009-41 identifies a specific commercial 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, labeled by Terumo Corporation. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Terumo Corporation on May 05, 2010. The current certification is valid through December 31, 2024.

How is this Terumo Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53877000941. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
53877-009-41
11-Digit CMS (5-4-2)
53877-0009-41

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.