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DEVICE DETAILS

NAME OF DEVICEFULL FACE MASK
ESTABLISHMENT NAMEROCKY SCIENTIFIC INSTRUMENTATION
REGISTRATION NOGB10513320-46033
BRAND NAMEBMC
DEVICE GROUPING TYPESINGLE
DEVICE DESCRIPTIONMask 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 PURPOSEThe 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 REGISTRATION08/07/2020 - 07/07/2025

LIST OF DEVICE

NONAME OF DEVICEDEVICE IDENTIFIER
1FULL FACE MASKF3
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