Vigilant Drug'Lib AGILIA US Z073476

GUDID 04052682034121

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

Fresenius Kabi AG

Infusion pump medication-dosage application software
Primary Device ID04052682034121
NIH Device Record Keya872fa76-2db1-408e-8a93-7c2b775e687c
Commercial Distribution StatusIn Commercial Distribution
Brand NameVigilant Drug'Lib AGILIA US
Version Model Number1.2
Catalog NumberZ073476
Company DUNS315654579
Company NameFresenius Kabi AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104052682034121 [Primary]
GS104052682036460 [Primary]
GS104086000851831 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRNPump, Infusion

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-01-22
Device Publish Date2019-07-15