DEVICE DETAILS
| NAME OF DEVICE | FULL FACE MASK |
|---|---|
| ESTABLISHMENT NAME | ROCKY SCIENTIFIC INSTRUMENTATION |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GB6254821-63660 |
| 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. F3 Full Face Masks have good safety performance and it is suitable for clinical, simple and safe operation. |
| DEVICE INTENDED PURPOSE | The F3 Full Face Mask channels airflow from ventilator systems non-invasively to the patients who suffer from obstructive sleep apnea (OSA) or respiratory insufficiency and respiratory failure. - The mask is to be used by adult patients (> 30 kg) requiring non-life-support ventilator assistance. - The mask is intended for single-patient use,for a maximum of seven days, in the hospital or clinical environment. |
| VALIDITY DATE OF REGISTRATION | 11/06/2021 - 10/06/2026 |