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BPR MEDICAL LIMITED · Model Firesafe Nozzle - DISS · UDI-DI 05060274502858
CAX
Prescription
10
510(k) clearances
157
Adverse events (15 deaths)
1
Recalls
45
Facilities
Description
Firesafe Nozzle - DISS. The intended medical purpose is to act as part of a conduit assembly through which oxygen is delivered to patients during normobaric oxygen therapy. A further non-medical purpose is to extinguish a fire in oxygen therapy tubing and isolate the oxygen supply. The non-medical purpose is further described in the technical description below.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2008-08-26 | Porter Instrument Co Inc | inverted check value on the bag tee assembly which can cause leaking of mixed N2O/O2 gas |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.