Duns Number:315654579
Device Description: For use with Agilia VP MC pumps / Volumat MC Agilia pump or gravity only.
Catalog Number
M46445475
Brand Name
Volumat™ Line
Version/Model Number
VL SP40-11
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
d47d3bb3-bafe-4ee6-8f21-aecac4f15994
Public Version Date
September 07, 2022
Public Version Number
3
DI Record Publish Date
August 28, 2018
Package DI Number
04250273733877
Quantity per Package
30
Contains DI Package
04250273733860
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 |