Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)
NDC Package 53877-001-01
Package Information
Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1) is issued 2011-11 N-BB-CA-A-DB(2)BB89X404+2TERUFLEX BLOOD BAG SYSTEM with Diversion Blood Sampling ArmCPDA-1 SOLUTIONFor the collection of 450 mL and 500 mL of Whole BloodFULL PRESCRIBING INFORMATION*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 8, 9, 10, 12, 13, 14, 15 and 17].1. INDICATIONS AND USAGE1.1. Read these instructions carefully before use.1.2. Rx ONLY1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Marketed by Terumo Corporation, this product is identified by NDC 53877-001 and is authorized under FDA application BN820528.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 53877 - Terumo Corporation
- 53877-001 - Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)
- 53877-001-01 - 30 BAG in 1 CASE / 35 mL in 1 BAG
- 53877-001 - Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)
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 (53877-001). Click a package code to view its specific billing and regulatory data.
* 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 53877-001-01 identifies a specific commercial package of 30 bag in 1 case / 35 ml in 1 bag of Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1), 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 22, 2012. 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: 53877000101. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
