Catalog Number

4R2001

Brand Name

Fenwal Transfer Pack Container 150 mL with Coupler

Version/Model Number

4R2001

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

e59f9c3c-82a8-4fbf-9b05-0a749aeb5fb7

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

April 09, 2019

Package DI Number

24052682004203

Quantity per Package

8

Contains DI Package

14052682004206

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box