Duns Number:315654579
Device Description: For use with the Volumat primary lines.
Catalog Number
M77460052
Brand Name
Volumat™ Line
Version/Model Number
VL SL00-XP
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
K121613,K121613
Product Code
FRN
Product Code Name
Pump, Infusion
Public Device Record Key
a95febbd-540f-4abd-a510-b216f239b8c7
Public Version Date
September 07, 2022
Public Version Number
3
DI Record Publish Date
August 28, 2018
Package DI Number
04250273733891
Quantity per Package
40
Contains DI Package
04250273733884
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 87 |
| U | Unclassified | 2 |