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 ID: 04052682034121
• NIH Device Record Key: a872fa76-2db1-408e-8a93-7c2b775e687c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vigilant Drug'Lib AGILIA US
• Version Model Number: 1.2
• Catalog Number: Z073476
• Company DUNS: 315654579
• Company Name: Fresenius Kabi AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04052682034121 [Primary]
GS1	04052682036460 [Primary]
GS1	04086000851831 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121613

FDA Product Code

• FRN: Pump, Infusion

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-01-22
• Device Publish Date: 2019-07-15