DEVICE DETAILS
| NAME OF DEVICE | NASAL MASK / NASAL PILLOWS INTERFACE / FULL FACE MASK |
|---|---|
| ESTABLISHMENT NAME | ROCKY SCIENTIFIC INSTRUMENTATION |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GB10318220-46798 |
| BRAND NAME | BMC |
| MEDICAL DEVICE CATEGORY | MD 0101 - Non-active devices for anaesthesia, emergency and intensive care |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | Mask covers patient’s nose while the adjustable headgear straps hold the mask in place. Headgear Straps that are too loose permit air to leak while too tights traps can break the seal and create leaks; any strap pulled too tightly can cause discomfort. Headgear straps are snug enough for a good fit in all sleeping positions (side and front) but not tight. The straps loop into the hooks on the frame, and they both allow for quick, easy removal of the mask. |
| DEVICE INTENDED PURPOSE | The Mask channels airflow non-invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system. The Mask is: - to be used by adult patients (> 66 lb / 30 kg) for whom positive airway pressure therapy has been prescribed. - intended for single-patient re-use in the home environment and multi-patient re-use in the hospital / institutional environment. |
| VALIDITY DATE OF REGISTRATION | 08/09/2020 - 07/09/2025 |