Catalog Number

-

Brand Name

B-COOL 3.0 COLD PACK 5.5" X 11"

Version/Model Number

08140611

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

IME

Product Code Name

Pack, Hot Or Cold, Reusable

Public Device Record Key

81e9e0fd-32f6-4c28-8f62-60afe87a49d3

Public Version Date

September 07, 2022

Public Version Number

1

DI Record Publish Date

August 30, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-