Duns Number:830016148
Device Description: 3M™ Bair Hugger™ NovaPlus™ Large Pediatric Underbody Blanket, 10 per case, 45034
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
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
DWJ
Product Code Name
System, thermal regulating
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
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 |