Vigilant Software Suite
Vigilant Master Med creates and manages drug libraries and device configurations for compatible Fresenius Kabi infusion pumps. It is the drug library component of the Vigilant Software…
Vigilant Master Med creates and manages drug libraries and device configurations for compatible Fresenius Kabi infusion pumps. It is the drug library component of the Vigilant Software Suite and part of a dose error reduction system.
Pharmacists define medication limits according to institutional policies. Those limits, therapies and profiles are uploaded to compatible pumps, which notify clinicians when a programmed dose is outside the configured range.
Listed Item
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.
Patient and Device Scope
The software supports drug library configurations for adult, pediatric and neonatal infusion care. It manages the library data rather than directly delivering medication, with dose checking performed by the compatible infusion device using the supplied limits.
Who Else Makes It
Registered in Shanghai. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
Record
| Listed by | Fresenius Kabi AB, Sweden |
|---|---|
| FDA product code | PHC |
| Device type | Infusion Safety Management Software |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Establishment | Contract manufacturer, Contract steriliser, Manufacturer |
| 510(k) | K210075 |
| Record published | 2022-05-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ZK288122 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ivenix Infusion System | Fresenius Kabi AB | 6 |
| BD Intelliport | Becton, Dickinson AND Company | 5 |
| PharmGuard | ICU Medical, Inc | 4 |
| LifeShield Infusion Safety Software Suite | ICU Medical, Inc | 3 |
| Dose IQ Safety Software | Baxter Healthcare Corporation | 3 |
| Alaris | CareFusion 303, Inc | 3 |
| ICU Medical MedNet | ICU Medical, Inc | 3 |
| LifeShield Infusion Safety Software Suite – LifeShield CDR | ICU Medical, Inc | 2 |
| Alaris™ Guardrails™ Editor Software Kit, Model 8961 | CareFusion 303, Inc | 2 |
| BD Alaris | CareFusion 303, Inc | 1 |
| BD Alaris™ System Manager 9601, Software | CareFusion 303, Inc | 1 |
| BD Intelliport System | Becton, Dickinson AND Company | 1 |
Showing 12 of 20. All products under Infusion Safety Management Software
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K210075 | 2022-03-01 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.