Duns Number:830016148
Device Description: 3M™ Ranger™ Blood/Fluid Warming Standard Flow Set, 24200, 10/Case
Catalog Number
24200
Brand Name
3M™ Ranger™
Version/Model Number
24200
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
K973741,K973741
Product Code
BSB
Product Code Name
Warmer, blood, non-electromagnetic radiation
Public Device Record Key
26b42d52-673b-47e0-8204-fda58068b7df
Public Version Date
March 22, 2022
Public Version Number
2
DI Record Publish Date
June 21, 2021
Package DI Number
50707387792645
Quantity per Package
10
Contains DI Package
10707387792647
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| 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 |