FDA product code QDM: Midazolam Syringe
QDM is the FDA product code for midazolam syringe. It is a Class II device, regulated under 21 CFR 880.5860 and reviewed by the General Hospital panel. Devices under QDM reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Intended for intramuscular injection of midazolam.
Classification
| Field | Value |
|---|---|
| Device name | Midazolam Syringe |
| Device class | Class II |
| Regulation | 21 CFR 880.5860 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
Recalls for QDM devices
openFDA lists no recalls for product code QDM.
Frequently asked questions
What is FDA product code QDM?
QDM is the FDA product code for midazolam syringe. It is a Class II device, regulated under 21 CFR 880.5860 and reviewed by the General Hospital panel.
What device class is QDM?
Class II, regulation 21 CFR 880.5860. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QDM
- Run a recall and safety report across every QDM manufacturer
- Watch product code QDM 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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