Catalog Number

67533

Brand Name

3M™ Bair Hugger™

Version/Model Number

67533

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

K171373,K171373

Product Code

DWJ

Product Code Name

System, thermal regulating

Public Device Record Key

fdcae491-05c1-4986-a067-8935fa4a1adf

Public Version Date

March 22, 2021

Public Version Number

1

DI Record Publish Date

March 12, 2021

Package DI Number

50707387804072

Quantity per Package

1

Contains DI Package

00707387804077

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE