Catalog Number

-

Brand Name

IOB

Version/Model Number

IOB-026S

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

K190221,K190221

Product Code

DWJ

Product Code Name

System, Thermal Regulating

Public Device Record Key

4516a261-1800-4826-ba5d-fa148c6e6171

Public Version Date

March 29, 2022

Public Version Number

1

DI Record Publish Date

March 21, 2022

Package DI Number

20850035767768

Quantity per Package

40

Contains DI Package

00850035767764

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case