FDA product code QMX: Label Or Tag, Non-Sterile
QMX is the FDA product code for label or tag, non-sterile. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General Hospital panel. Devices under QMX reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
The device is intended to assist with identification of an IV infusion line used to administer fluids and/or drug products.
Classification
| Field | Value |
|---|---|
| Device name | Label Or Tag, Non-Sterile |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| Review panel | HO — General Hospital |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Recalls for QMX devices
openFDA lists no recalls for product code QMX.
Frequently asked questions
What is FDA product code QMX?
QMX is the FDA product code for label or tag, non-sterile. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General Hospital panel.
What device class is QMX?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code QMX
- Run a recall and safety report across every QMX manufacturer
- Watch product code QMX 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.
All General Hospital product codes · FDA product code lookup · 510(k) database search · 510(k) review times