Bair Hugger™ Novaplus™ - 3M™ Bair Hugger™ NovaPlus™ Large Pediatric - 3M COMPANY

Duns Number:830016148

Device Description: 3M™ Bair Hugger™ NovaPlus™ Large Pediatric Underbody Blanket, 10 per case, 45034

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More Product Details

Catalog Number

45034

Brand Name

Bair Hugger™ Novaplus™

Version/Model Number

45034

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

10d4e1c7-ab3b-4e19-87ed-b90db46d719f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

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