Haemonetics Additive Solution Formula 3 (as-3)
NDC Package 57826-460-02

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

Package Information

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

Haemonetics Additive Solution Formula 3 (as-3) is the Haemonetics 250mL Anticoagulant Citrate Phosphate Double Dextrose (CP2D) and 250mL Additive Solution Formula 3 (AS-3) nutrient solution are intended to be used only with automated apheresis devices for collecting human blood and blood components. Marketed by Haemonetics Corporation, this product is identified by NDC 57826-460 and is authorized under FDA application BN000127.

Identification & Billing

NDC Package Code
57826-460-02
Package Description
250 mL in 1 BAG
Product Code
57826-460
11-Digit Billing Format
57826046002

Clinical Specifications

Proprietary Name
Haemonetics Additive Solution Formula 3 (as-3)
Dosage Form
-
Usage Information
The Haemonetics 250mL Anticoagulant Citrate Phosphate Double Dextrose (CP2D) and 250mL Additive Solution Formula 3 (AS-3) nutrient solution are intended to be used only with automated apheresis devices for collecting human blood and blood components. The anticoagulant solution is metered by the apheresis machine into the collected whole blood. It is not to be infused directly into the donor. After the anticoagulant is used, the bag in which it was contained is discarded. When collecting plasma in the RBCP protocol, the plasma is collected into an empty plasma collection bag. One hundred milliliters (100ml) of AS-3 is transferred into one RBC collection bag when using the RBCP protocol or 2 separate bags when using the 2RBC protocol. AS-3 solution provides nutrients to keep the red blood cells viable for 42 days when refrigerated.CP2D is also indicated for the collection of FFP and PF24 plasma, collected and stored plasma collected using the 822, 822-2P and 822F-2P disposable sets may be frozen within 8 hours (FFP) or within 24 hours which includes 8 hours room temperature storage and 16 hours refrigeration storage (PF24). The 300mL AS-3 is used in conjunction with automated red blood cell washing devices. AS-3 serves as the nutrient solution for storage of the red blood cell product after deglycerolization. The red blood cells are washed using the Model 215 System. AS-3 is used for priming the disposable and for the last wash of the red blood cells. The washed cells are then re-suspended in 100mL of the AS-3 before transfer into a product collection bag or storage bag. Additive Solution Formula 3 (AS-3) provides nutrients to keep the washed red blood cells viable for up to 14 days after washing when refrigerated. Neither the CP2D nor the AS-3 container is used for the storage of blood or blood components.

Regulatory & Marketing

Labeler Name
Haemonetics Corporation
FDA Application #
BN000127
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-10-2013
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 57826-460-02 identifies a specific commercial package of 250 ml in 1 bag of Haemonetics Additive Solution Formula 3 (as-3), labeled by Haemonetics 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 Haemonetics Corporation on January 10, 2013. The current certification is valid through December 31, 2024.

How is this Haemonetics Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57826046002. 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)
57826-460-02
11-Digit CMS (5-4-2)
57826-0460-02

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