Catalog Number

-

Brand Name

IOB

Version/Model Number

IOB-001

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

DWJ

Product Code Name

System, Thermal Regulating

Public Device Record Key

5dfa0aa9-0319-4f45-a8a0-b6a54426c164

Public Version Date

October 25, 2022

Public Version Number

5

DI Record Publish Date

December 04, 2017

Package DI Number

26951013001097

Quantity per Package

40

Contains DI Package

06951013001093

Package Discontinue Date

October 24, 2022

Package Status

Not in Commercial Distribution

Package Type

Case