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O-Two Medical Technologies Inc · Model 02FM5210 · UDI-DI 07540195010352
BSJ
Prescription
10
510(k) clearances
115
Adverse events
1
Recalls
161
Facilities
Description
The Single-use cuff mask comes with an air cushion pad to provide comfort for the patient. It is designed to be positioned over a patient’s nose or mouth to direct oxygen or anesthetic gases or aerosols to the upper airway. The size #4 cuff mask 02FM5203 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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