IVX Cloud
The IVX Cloud (system) manages the administration, setup, and medication workflows for pharmacy IV devices, including tracking orders (requests) for preparations, reviewing device requests…
The IVX Cloud (system) manages the administration, setup, and medication workflows for pharmacy IV devices, including tracking orders (requests) for preparations, reviewing device requests assigned for compounding, customizing workflows and protocols for the IV Solutions products. The IVX Cloud is intended for use in conjunction with IV Solutions products and acts as a source database and web-based compounding operation service. It is used to manage compounding data and orders and makes the data available to users both locally and remotely.
Who Else Makes It
All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Yangzhou Xingwei Medical Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 5 |
| Yangzhou Weideli Trading Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 10 |
Record
| Listed by | Omnicell, Inc., United States |
|---|---|
| FDA product code | NEP |
| Device type | System/Device, Pharmacy Compounding |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-06-25 |
| Record revised | 2024-01-11 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2024-01-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IVX Cloud | In distribution | |
| IVX Cloud | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Exactamix | Baxter Healthcare Corporation | 27 |
| ICU Medical, Inc. | ICU Medical, Inc | 16 |
| Apex™ | B. Braun Medical Inc. | 15 |
| Pinnacle® | B. Braun Medical Inc. | 13 |
| System/Device, Pharmacy Compounding | Baxter Healthcare Corporation | 9 |
| DianaTM Compounding Workflow System | ICU Medical, Inc | 9 |
| Repeater | Baxter Healthcare Corporation | 8 |
| DianaTM Automated Drug Compounding System | ICU Medical, Inc | 5 |
| Single Lead High Volume Pump Chamber SET | MPS Pharma & Medical, Inc. | 4 |
| Abacus | Baxter Healthcare Corporation | 4 |
| Apoteca | AEA SRL | 3 |
| GRI-BAG | Laboratorios Grifols SA | 3 |
Showing 12 of 35. All products under System/Device, Pharmacy Compounding
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2026-03-25 | Class I | Process control | Potential for mislabeled syringe produced by the i.v.STATION device. | 220 units |
| 2023-03-27 | Class II | Under Investigation by firm | IVX Station does not account for inherent scale inaccuracy or variability, could result in a preparation being passed that is outside of the dose accuracy stated in the product labeling | 6 units |
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.