Duns Number:830016148
Device Description: 3M™ Bair Hugger™ Temperature Monitoring Patient Sensor, 36000, 25/Case
Catalog Number
36000
Brand Name
3M™ Bair Hugger™
Version/Model Number
36000
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"
-
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
K120412,K120412
Product Code
FLL
Product Code Name
Thermometer, electronic, clinical
Public Device Record Key
69cb9f32-df96-4b40-890e-d4cd411eed5d
Public Version Date
March 22, 2021
Public Version Number
1
DI Record Publish Date
March 12, 2021
Package DI Number
50707387792959
Quantity per Package
25
Contains DI Package
30707387792955
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| 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 |