FDA product code NZX: Water, Vascular Access Flush
NZX is the FDA product code for water, vascular access flush. It is a Class II device, regulated under 21 CFR 880.5200 and reviewed by the General Hospital panel. Devices under NZX reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.
Classification
| Field | Value |
|---|---|
| Device name | Water, Vascular Access Flush |
| Device class | Class II |
| Regulation | 21 CFR 880.5200 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
Recalls for NZX devices
openFDA lists no recalls for product code NZX.
Frequently asked questions
What is FDA product code NZX?
NZX is the FDA product code for water, vascular access flush. It is a Class II device, regulated under 21 CFR 880.5200 and reviewed by the General Hospital panel.
What device class is NZX?
Class II, regulation 21 CFR 880.5200. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NZX
- Run a recall and safety report across every NZX manufacturer
- Watch product code NZX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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