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Hanwell
Ningbo Hanyue Medical Technology Co., Ltd. · Model L · UDI-DI 06975834950583
10
510(k) clearances
29
Adverse events
3
Recalls
94
Facilities
Description
Continuous Positive Airway Pressure (CPAP) mask provides the continuous positive airway pressure to treat obstructive sleep apnea(OSA), hypopnea, air flow restrictions and snoring. Made from medical grade Silicone, have good biocompatibility. Provide a good seal when fitted to the patient. Features a 360 degree dual swivel elbow port to move freely. The ultra-flexible forehead support reduces contact with your skin.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-03-25 | Salter Laboratories, Division of Regulatory Affairs | A small number of oxygen mask components were found to have 100% obstructed airways rendering them incapable of delivering oxygen to patients undergoing respiration therapy. |
| 2011-02-11 | Smiths Medical | A sticky substance on the inside and/ or outside of the Mask |
| 2011-02-11 | Smiths Medical | A sticky substance on the inside and/ or outside of the Mask |
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