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O-Two
O-Two Medical Technologies Inc · Model 02FM5000 · UDI-DI 07540195010024
10
510(k) clearances
115
Adverse events
1
Recalls
161
Facilities
Description
O-Two Resuscitation and Anesthesia Facemasks are intended to be used with automatic ventilator/manual resuscitator or anesthesia machine to provide a mask to face seal which covers both mouth and nose during resuscitation or anesthesia. The clear PVC facemask is ideal for use where disinfection after use is normally undertaken by cold chemical sterilant. The medium mask 02FM5000 fits adult patients.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-09-12 | Engineered Medical Systems,Inc | The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates. |
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