Duns Number:830016148
Device Description: 3M™ Bair Paws Flex™ Warming Gown Kit, Standard, 20 Per Case 84003
Catalog Number
84003
Brand Name
Bair Paws™
Version/Model Number
84003
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 23, 2016
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
1a4bac96-e56f-4340-8a93-fb64c038b551
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 |