Catalog Number

10601

Brand Name

BREG

Version/Model Number

POLAR CARE KODIAK

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

ILO

Product Code Name

Pack, Hot Or Cold, Water Circulating

Public Device Record Key

e45dc8b4-0dba-4f6a-8081-5bc7be4d143b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 15, 2016

Package DI Number

40672736000708

Quantity per Package

6

Contains DI Package

00672736000625

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bulk 6 pack