Catalog Number

8100

Brand Name

HemoCool Gel-Pak

Version/Model Number

8100

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 12, 2022

Issuing Agency

In HIBCC

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

KSE

Product Code Name

Refrigerator, Freezer, Blood Storage

Public Device Record Key

0c35b892-721d-4b02-8e32-2feff178602f

Public Version Date

May 12, 2022

Public Version Number

3

DI Record Publish Date

January 10, 2018

Package DI Number

M74481001

Quantity per Package

6

Contains DI Package

M74481000

Package Discontinue Date

February 12, 2022

Package Status

Not in Commercial Distribution

Package Type

Case