3M™ Bair Hugger™ - 3M™ Bair Hugger™ Warming Blanket 54200, Dual Port - 3M COMPANY

Duns Number:830016148

Device Description: 3M™ Bair Hugger™ Warming Blanket 54200, Dual Port Torso, 10/Case

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More Product Details

Catalog Number

54200

Brand Name

3M™ Bair Hugger™

Version/Model Number

54200

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

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 Details

Product Code

DWJ

Product Code Name

System, thermal regulating

Device Record Status

Public Device Record Key

baee2695-7c02-4185-bdd4-a6c632832b0f

Public Version Date

March 24, 2022

Public Version Number

1

DI Record Publish Date

March 16, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"3M COMPANY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 274
2 A medical device with a moderate to high risk that requires special controls. 444
U Unclassified 7