Identifiers
- 510(k) Number
- K212530 FDA 510(k)
- FDA Product Code
- LHI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5440 FDA 510(k)
- Regulation Number
- 880.5440 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The IVX Fluid Transfer Set is a medical device designed for fluid transfer in hospital settings. It is classified under product code LHI and is intended for use in general hospital environments.
The device is supplied by Omnicell, Inc. and received FDA 510K clearance on April 24, 2022. It is substantially equivalent to predicate devices and is not indicated for single-use or reuse. The device is available in various sizes and models as specified by the manufacturer.
Frequently asked questions
What is the IVX Fluid Transfer Set used for?
The IVX Fluid Transfer Set is designed for fluid transfer in general hospital environments. It is a medical device intended for use in hospital settings to facilitate the transfer of fluids between containers or systems.
Is the IVX Fluid Transfer Set single-use or reusable?
The IVX Fluid Transfer Set is not indicated for single-use or reuse. It is designed for multiple uses in hospital settings, though specific cleaning and maintenance protocols should be followed as per manufacturer guidelines.
What sizes and models are available for the IVX Fluid Transfer Set?
The IVX Fluid Transfer Set is available in various sizes and models as specified by the manufacturer, Omnicell, Inc. The specific options would need to be confirmed with the manufacturer based on the hospital's requirements.
What is the regulatory status of the IVX Fluid Transfer Set?
The IVX Fluid Transfer Set received FDA 510K clearance on April 24, 2022. It is classified under product code LHI and is substantially equivalent to predicate devices, making it suitable for use in general hospital environments.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212530 | Class II | Active |
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Manufacturer
- Manufacturer
- Omnicell, Inc.
Sources (1)
- FDA 510(k) K212530 24 fields · synced Sep 21, 2026