Catalog Number

4R2422

Brand Name

Fenwal Red Cell Freezing Pack 2000 mL

Version/Model Number

4R2422

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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KSR

Product Code Name

Container, Empty, For Collection & Processing Of Blood & Blood Components

Public Device Record Key

2416ff4e-addc-4baf-a001-7bb80ca9be2e

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

June 23, 2020

Package DI Number

14052682004251

Quantity per Package

48

Contains DI Package

04052682004254

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box