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O-Two
O-Two Medical Technologies Inc · Model 02FM5097 · UDI-DI 07540195010109
BSJ
Prescription
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 Silicone facemasks are ideal for anesthesia as they withstand repeated autoclaving. The universal silicone mask 02FM5097 fits patients from infant to Adult adult.
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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