Catalog Number

-

Brand Name

Kozee

Version/Model Number

M21304

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DWJ

Product Code Name

System, Thermal Regulating

Public Device Record Key

5b3fae0a-d43e-45a0-a0f0-1d72af6c89bc

Public Version Date

December 06, 2021

Public Version Number

3

DI Record Publish Date

January 27, 2020

Package DI Number

18973920006973

Quantity per Package

40

Contains DI Package

08973920006723

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box