Duns Number:830016148
Device Description: 3M™ Ranger™ Fluid Warming Unit, Model 245, 120V-ENG-E, Military , 1 each, 24533
Catalog Number
24533
Brand Name
Ranger™
Version/Model Number
24533
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 14, 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
K973741
Product Code
BSB
Product Code Name
Warmer, blood, non-electromagnetic radiation
Public Device Record Key
95ce6caf-5891-4f99-88d7-9df5685fc0cb
Public Version Date
March 22, 2022
Public Version Number
4
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 |