Teruflex Blood With Diversion Blood Sampling Arm Anticoagulant Cpd With Optisol Red Cell Preservative For Collection Of 450ml Of Blood Kit
NDC Package 53877-101-06

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

Package Information

Teruflex Blood With Diversion Blood Sampling Arm Anticoagulant Cpd With Optisol Red Cell Preservative For Collection Of 450ml Of Blood (dextrose monohydrate, trisodium citrate dihydrate, anhydrous citric acid, sodium phosphate, monobasic, unspecified form, sodium chloride, mannitol, and adenine) kits is 1.1. This formulation utilizes a kit delivery system. Marketed by Terumo Corporation, this product is identified by NDC 53877-101 and is authorized under FDA application BN880217.

Identification & Billing

NDC Package Code
53877-101-06
Package Description
6 BLISTER PACK in 1 CASE / 4 BAG in 1 BLISTER PACK (53877-101-01) / 1 KIT in 1 BAG (53877-101-02) * 63 mL in 1 BAG (53877-111-63) * 100 mL in 1 BAG (53877-121-10)
Product Code
53877-101
11-Digit Billing Format
53877010106

Clinical Specifications

Proprietary Name
Teruflex Blood With Diversion Blood Sampling Arm Anticoagulant Cpd With Optisol Red Cell Preservative For Collection Of 450ml Of Blood
Non-Proprietary Name
Dextrose Monohydrate, Trisodium Citrate Dihydrate, Anhydrous Citric Acid, Sodium Phosphate, Monobasic, Unspecified Form, Sodium Chloride, Mannitol, And Adenine
Dosage Form
Kit - A packaged collection of related material.
Administration Route
Intravenous - Administration within or into a vein or veins.
Usage Information
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.

Regulatory & Marketing

Labeler Name
Terumo Corporation
Product Type
Human Prescription Drug
FDA Application #
BN880217
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-05-2010
Listing Expiration
12-31-2026
Exclude Flag
N
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 53877-101-06 identifies a specific commercial package of 6 blister pack in 1 case / 4 bag in 1 blister pack (53877-101-01) / 1 kit in 1 bag (53877-101-02) * 63 ml in 1 bag (53877-111-63) * 100 ml in 1 bag (53877-121-10) of Teruflex Blood With Diversion Blood Sampling Arm Anticoagulant Cpd With Optisol Red Cell Preservative For Collection Of 450ml Of Blood, a human prescription drug labeled by Terumo Corporation. This kit is formulated for intravenous use and contains as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Terumo Corporation on May 05, 2010. The current certification is valid through December 31, 2026.

How is this Terumo Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53877010106. 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)
53877-101-06
11-Digit CMS (5-4-2)
53877-0101-06

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