Identity
- Trade Name
- Vigilant Drug'Lib AGILIA US FDA UDI
- Generic Name
- Infusion pump medication-dosage application software FDA UDI
- Device Name
- 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 FDA UDI
- Model / Reference
- 1.2 FDA UDI
- 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 FDA UDI
Identifiers
- Catalog Number
- Z073476 FDA UDI
- Primary DI / UDI-DI
- 04052682034121 FDA UDI
- 510(k) Number
- K121613 FDA UDI
- FDA Product Code
- FRN FDA UDI
- GMDN Term
- Infusion pump medication-dosage application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Infusion pump medication-dosage application software
Vigilant Drug'Lib AGILIA US by Fresenius Kabi — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Infusion pump medication-dosage application software.
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- CADD — ICU MEDICAL, INC. · Class II
Cleared under the same submission
K121613 also covers:
- AGILIA USB CABLE US — Fresenius Kabi
- Secondary Line — Fresenius Kabi
- Secondary Line — Fresenius Kabi
- VOLUMAT MC AGILIA US — Fresenius Kabi
- Vigilant Drug'Lib AGILIA US — Fresenius Kabi
- Vigilant Drug'Lib AGILIA US — Fresenius Kabi
- Volumat™ Line — Fresenius Kabi
- Volumat™ Line — Fresenius Kabi
- Volumat™ Line — Fresenius Kabi
- Volumat™ Line — Fresenius Kabi
- Volumat™ Line — Fresenius Kabi
- Volumat™ Line — Fresenius Kabi
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Fresenius Kabi
Sources (1)
- FDA UDI a872fa76-2db1-408e-8a93-7c2b775e687c 35 fields · synced May 30, 2026