Duns Number:830016148
Device Description: 3M™ Bair Hugger® Patient Warming Unit, Model 795, 120V-ENG-E, Refurbished 79500
Catalog Number
79500
Brand Name
Bair Hugger™
Version/Model Number
79500
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 01, 2017
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
K060865
Product Code
DWJ
Product Code Name
System, thermal regulating
Public Device Record Key
4b3add89-0b71-4866-959b-aa986d8eb4f7
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 |