Identity
- Trade Name
- Vigilant Software Suite FDA UDI
- Generic Name
- Infusion pump medication-dosage application software FDA UDI
- Device Name
- Vigilant Master Med is a component of the Vigilant Software Suite. Vigilant Master Med is part of a Dose Error Reduction System (DERS) for use with Adults, Pediatrics, and Neonates. It is intended to create, customize, and manage drug library data and device configurations to be uploaded to compatible Fresenius Kabi infusion devices which may reduce the risk of drug administration errors. It enhances safety by preventing infusion errors with the use of Dose Error Reduction System (DERS) in combination with the infusion devices. FDA UDI
- Model / Reference
- ZK288122 FDA UDI
- Description
- Vigilant Master Med is a component of the Vigilant Software Suite. Vigilant Master Med is part of a Dose Error Reduction System (DERS) for use with Adults, Pediatrics, and Neonates. It is intended to create, customize, and manage drug library data and device configurations to be uploaded to compatible Fresenius Kabi infusion devices which may reduce the risk of drug administration errors. It enhances safety by preventing infusion errors with the use of Dose Error Reduction System (DERS) in combination with the infusion devices. FDA UDI
Identifiers
- Catalog Number
- ZK288122 FDA UDI
- Primary DI / UDI-DI
- 04052682044106 FDA UDI
- 510(k) Number
- K210075 FDA UDI
- FDA Product Code
- PHC 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 Software Suite by Fresenius Kabi — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Infusion pump medication-dosage application software.
- DOSE IQ SAFETY SOFTWARE — Baxter Healthcare Corp · Class II
- Medfusion — ICU MEDICAL, INC. · Class II
- LifeShield Infusion Safety Software Suite — ICU MEDICAL FLEET SERVICES, LLC · Class II
- ICU Medical MedNet — ICU MEDICAL, INC. · Class II
- MEDFUSION — ICU MEDICAL, INC. · Class II
- EndoTool IV — Monarch Medical Technologies, LLC · Class II
- CADD — ICU MEDICAL, INC. · Class II
- CADD — ICU MEDICAL, INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fresenius Kabi
Sources (1)
- FDA UDI d0e60e6c-1e4f-4ad3-9b4b-951d816c54c9 35 fields · synced Jun 1, 2026