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DEVICE DETAILS

NAME OF DEVICEYUWELL SLEEP APNEA BREATHING THERAPY MASK (FULL FACE MASK)
ESTABLISHMENT NAMERBD HEALTHCARE SDN BHD
REGISTRATION NOGB7838322-113641
BRAND NAMEYUWELL
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONThe mask is a noninvasive accessory used for channeling airflow (With or without supplemental oxygen) to a patient from a positive airway. Pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel system. The mask is to be used by patients (weighing>30kg), intended for single- patient reuse in the home environment. The mask is intended for single-patient use in the hospital or institutional environment.
DEVICE INTENDED PURPOSEThe mask is a noninvasive accessory used for channeling airflow (With or without supplemental oxygen) to a patient from a positive airway.
VALIDITY DATE OF REGISTRATION23/12/2022 - 22/12/2027

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1SLEEP APNEA BREATHING THERAPY MASKYF-01
2SLEEP APNEA BREATHING THERAPY MASKYF-02
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