Duns Number:830016148
Device Description: 3M™ Ranger® Fluid Warming Set, Standard Flow, 10 Per Case 24110
Catalog Number
24110
Brand Name
Bair Hugger™
Version/Model Number
24110
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
BK940032,BK940032
Product Code
KZL
Product Code Name
DEVICE, WARMING. BLOOD AND PLASMA
Public Device Record Key
5b8861cd-c38b-4d67-887c-ddd72883ed79
Public Version Date
March 22, 2022
Public Version Number
4
DI Record Publish Date
January 30, 2017
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 |