Vigilant Drug'Lib AGILIA US

Basic Information

• Brand Name: Vigilant Drug'Lib AGILIA US
• Primary DI: 04086000851831
• Version / Model: 1.1
• Catalog Number: Z073476
• Company Name: Fresenius Kabi AG
• Labeler DUNS: 315654579
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-23
• Public Version: 3
• Public Version Date: 2021-11-08
• Public Version Status: Update
• Public Device Record Key: 1bd73dfe-baf2-42a2-81d6-4c5cdb1141e3

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRN	Pump, Infusion	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47903	Infusion pump medication-dosage application software	A software program intended to enable a healthcare professional to create, modify and store (manage) dosage parameters (protocols) for delivery of medication by an electronic infusion pump(s) or a syringe pump(s) which is used in a hospital/institution (e.g., IV pole mounted) or used for ambulatory purposes [also known as computerized ambulatory drug delivery (CADD)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04086000851831	GS1

Premarket Submissions

Submission Number	Supplement Number
K121613	000