Catalog Number

-

Brand Name

IOB

Version/Model Number

IOB-004

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

K162679,K162679

Product Code

DWJ

Product Code Name

System, Thermal Regulating

Public Device Record Key

50061f4d-e34b-4577-80e2-756852e4cb28

Public Version Date

March 16, 2022

Public Version Number

1

DI Record Publish Date

March 08, 2022

Package DI Number

20850035767041

Quantity per Package

40

Contains DI Package

00850035767047

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-