Duns Number:830016148
Device Description: 3M™ Ranger™ Fluid Warming Irrigation Set, 24750, 10/Case
Catalog Number
24750
Brand Name
3M™ Ranger™
Version/Model Number
24750
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
K060939,K060939
Product Code
LGZ
Product Code Name
Warmer, thermal, infusion fluid
Public Device Record Key
fe702402-f383-4d74-a14b-85b687ca8092
Public Version Date
June 29, 2021
Public Version Number
1
DI Record Publish Date
June 21, 2021
Package DI Number
50707387792720
Quantity per Package
10
Contains DI Package
10707387792722
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 |