Duns Number:080720061
Device Description: The Omnicell IVX Station is intended for use in the automated preparation of pharmaceutica 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.
Catalog Number
-
Brand Name
IVX Station
Version/Model Number
IVX Station
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NEP
Product Code Name
System/Device, Pharmacy Compounding
Public Device Record Key
495fb1b4-8819-42fe-baa1-f501670bb912
Public Version Date
February 16, 2021
Public Version Number
1
DI Record Publish Date
February 08, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |