Catalog Number

89501

Brand Name

3M™ Bair Hugger™

Version/Model Number

89501

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

-

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

K060865,K060865

Product Code

DWJ

Product Code Name

System, thermal regulating

Public Device Record Key

1e05b044-0df2-4685-a794-1c19bd9a3e31

Public Version Date

December 01, 2021

Public Version Number

1

DI Record Publish Date

November 23, 2021

Package DI Number

50707387808971

Quantity per Package

1

Contains DI Package

00707387808976

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX