DEVICE DETAILS
| NAME OF DEVICE | DREAMWEAR FULL FACE MASK |
|---|---|
| ESTABLISHMENT NAME | PHILIPS MALAYSIA SDN BERHAD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GB910651134618 |
| BRAND NAME | RESPIRONICS |
| MEDICAL DEVICE CATEGORY | MD 0101 - Non-active devices for anaesthesia, emergency and intensive care |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | THE DREAMWEAR FULL FACE MASK IS INTENDED TO PROVIDE AN INTERFACE FOR APPLICATION OF CPAP OR BI-LEVEL THERAPY TO PATIENTS. THE MASK IS FOR SINGLE PATIENT USE IN THE HOME OR MULTI-PATIENT USE IN THE HOSPITAL/INSTITUTIONAL ENVIRONMENT. THE MASK IS TO BE USED ON PATIENTS (>66LBS/30KG) FOR WHOM CPAP THERAPY OR BI-LEVEL THERAPY HAS BEEN PRESCRIBED. DREAMWEAR DESIGN ALLOWS PATIENTS TO QUICKLY AND EASILY SWITCH BETWEEN FULL FACE, NASAL AND GEL PILLOWS CUSHIONS WITHOUT CHANGING MASKS. |
| DEVICE INTENDED PURPOSE | THIS MASK IS INTENDED TO PROVIDE AN INTERFACE FOR APPLICATION OF CPAP OR BI-LEVEL THERAPY TO PATIENTS. THE MASK IS FOR SINGLE PATIENT USE IN THE HOME OR MULTI-PATIENT USE IN THE HOSPITAL/INSTITUTIONAL ENVIRONMENT. THE MASK IS TO BE USED ON PATIENTS (>66LBS/30KG) FOR WHOM CPAP THERAPY OR BI-LEVEL THERAPY HAS BEEN PRESCRIBED. |
| VALIDITY DATE OF REGISTRATION | 26/09/2023 - 25/09/2028 |