Catalog Number

4B7870

Brand Name

NA

Version/Model Number

4B7870

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KSW

Product Code Name

SYSTEM, PROCESSING FOR FROZEN BLOOD

Public Device Record Key

72adfde1-4d9c-4baa-9bd4-321e0c1e22a1

Public Version Date

October 11, 2022

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

60085412081900

Quantity per Package

14

Contains DI Package

00085412081908

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE