Identity
- Trade Name
- IVX Station FDA UDI
- Generic Name
- Intravenous solution compounder FDA UDI
- Device Name
- The Omnicell IVX Station is intended for use in the automated preparation of pharmaceutical admixtures and syringes consisting of Non-hazardous drugs and diluents, or, Hazardous drugs compounded in non-hazardous Primary Engineering Controls (PECs) as a result of site-specific hazard risk analysis, to be used for intravenous administration. FDA UDI
- Model / Reference
- IVX Station FDA UDI
- Description
- The Omnicell IVX Station is intended for use in the automated preparation of pharmaceutical admixtures and syringes consisting of Non-hazardous drugs and diluents, or, Hazardous drugs compounded in non-hazardous Primary Engineering Controls (PECs) as a result of site-specific hazard risk analysis, to be used for intravenous administration. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860006285005 FDA UDI
- FDA Product Code
- NEP FDA UDI
- GMDN Term
- Intravenous solution compounder FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 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
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Intravenous solution compounder
IVX Station by Omnicell, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Omnicell, Inc.
Sources (1)
- FDA UDI 495fb1b4-8819-42fe-baa1-f501670bb912 33 fields · synced May 30, 2026