Ivenix, Inc.
Infusion Management System (IMS), version 2.0
1manufacturer
1catalogue number
1510(k) clearance
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 |
| Record published | 2020-08-06 |
| Record revised | 2023-08-21 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2021-03-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2.0 | Withdrawn |
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 |
| Vigilant Software Suite | Fresenius Kabi AB | 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.