DEVICE DETAILS
| NAME OF DEVICE | QUATTRO AIR FULL FACE MASK |
|---|---|
| ESTABLISHMENT NAME | RESMED MALAYSIA OPERATIONS SDN. BHD. |
| REGISTRATION NO | GB75964191917 |
| BRAND NAME | RESMED |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | THE QUATTRO AIR AND QUATTRO AIR FOR HER IS AN ACCESSORY THAT IS EXTERNALLY PLACED COVERING THE MOUTH AND THE NOSE OF A PATIENT TO CHANNEL AIR FLOW FROM NON-CONTINUOUS POSITIVE AIRWAY PRESSURE VENTILATORS (CPAP OR BI-LEVEL FLOW GENERATORS) TO THE PATIENT FOR THE TREATMENT OF OBSTRUCTIVE SLEEP APNEA (OSA) OR VENTILATORY SUPPORT. IT ACHIEVES BOTH OF THESE THERAPY FUNCTIONS BY PROVIDING A SEAL FROM THE PAP DEVICE TO THE PATIENT%u2019S NOSE, THEREBY ENABLING THE DELIVERY OF POSITIVE AIR PRESSURE GENERATED BY THE PAP DEVICE TO THE PATIENT%u2019S AIRWAY |
| DEVICE INTENDED PURPOSE | THE QUATTRO AIR MASK SYSTEMS ARE A NON-INVASIVE ACCESSORIES USED FOR CHANNELLING AIR-FLOW (WITH OR WITHOUT SUPPLEMENTAL OXYGEN) TO A PATIENT FROM A POSITIVE AIRWAY PRESSURE DEVICE SUCH AS CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) OR BILEVEL SYSTEM. THE QUATTRO AIR MASK SYSTEMS ARE: - TO BE USED BY PATIENTS (WEIGHING >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 | 10/11/2021 - 09/11/2026 |