Catalog Number

791-05

Brand Name

Pall® Freezing Bag 25 mL with Separable Chamber

Version/Model Number

791-05

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"

Yes

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

2bd9d2c3-5c30-453d-b4be-99885e39f683

Public Version Date

September 23, 2019

Public Version Number

3

DI Record Publish Date

June 01, 2016

Package DI Number

30636207302466

Quantity per Package

24

Contains DI Package

00636207302465

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case