Duns Number:315654579
Device Description: Vigilant Drug'Lib AGILIA US is a dose error reduction software. It is installed on a PC Pl Vigilant Drug'Lib AGILIA US is a dose error reduction software. It is installed on a PC Platform for communication with the Volumat MC Agilia infusion pump via a USB cable
Catalog Number
Z073476
Brand Name
Vigilant Drug'Lib AGILIA US
Version/Model Number
1.2
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
K121613,K121613
Product Code
FRN
Product Code Name
Pump, Infusion
Public Device Record Key
a872fa76-2db1-408e-8a93-7c2b775e687c
Public Version Date
November 08, 2021
Public Version Number
3
DI Record Publish Date
July 15, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |