Catalog Number

4R2255P

Brand Name

Fenwal Quadruple TRANSFER-PACK Container With Male Luer Adapter

Version/Model Number

4R2255P

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

2bf11874-a608-4e85-96f2-5cd580110d29

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

September 02, 2016

Package DI Number

14086000101469

Quantity per Package

30

Contains DI Package

04086000101462

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton