Duns Number:830016148
Device Description: 3M™ Ranger™ Fluid Warming Unit, 29500, Model 295, 120V-ENG-E, Refurbished
Catalog Number
29500
Brand Name
3M™ Ranger™
Version/Model Number
29500
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
K973741,K973741
Product Code
BSB
Product Code Name
Warmer, blood, non-electromagnetic radiation
Public Device Record Key
f04385c5-0710-4114-a871-761d8e02be15
Public Version Date
March 22, 2022
Public Version Number
2
DI Record Publish Date
March 10, 2021
Package DI Number
50707387803419
Quantity per Package
1
Contains DI Package
00707387803414
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 |