FDA product code BSD: Analyzer, Gas, Nitrogen, Partial Pressure, Blood-Phase, Non-Indwelling
BSD is the FDA product code for analyzer, gas, nitrogen, partial pressure, blood-phase, non-indwelling. It is a Class III device, reviewed by the Anesthesiology panel. Devices under BSD reach the market by PMA; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Analyzer, Gas, Nitrogen, Partial Pressure, Blood-Phase, Non-Indwelling |
| Device class | Class III |
| Review panel | AN — Anesthesiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for BSD devices
openFDA lists no recalls for product code BSD.
Frequently asked questions
What is FDA product code BSD?
BSD is the FDA product code for analyzer, gas, nitrogen, partial pressure, blood-phase, non-indwelling. It is a Class III device, reviewed by the Anesthesiology panel.
What device class is BSD?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code BSD
- Run a recall and safety report across every BSD manufacturer
- Watch product code BSD 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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