Catalog Number

77500

Brand Name

3M™ Bair Hugger™

Version/Model Number

77500

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

1bc77549-748c-4bf8-bc76-0d1e4de6f3a2

Public Version Date

March 22, 2021

Public Version Number

1

DI Record Publish Date

March 12, 2021

Package DI Number

50707387803587

Quantity per Package

1

Contains DI Package

00707387803582

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE