DEVICE DETAILS
| NAME OF DEVICE | PERFORMAX PEDIATRIC SE TOTAL FACE MASK |
|---|---|
| ESTABLISHMENT NAME | PHILIPS MALAYSIA SDN BERHAD |
| REGISTRATION NO | GB821231357119 |
| BRAND NAME | PHILIPS RESPIRONICS |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | THE PERFORMAX PEDIATRIC SE TOTAL FACE MASK IS INTENDED TO PROVIDE A PATIENT INTERFACE FOR APPLICATION OF NONINVASIVE VENTILATION WHEN USED AS AN ACCESSORY TO VENTILATORS WHICH HAVE ADEQUATE ALARMS AND SAFETY SYSTEMS FOR VENTILATOR FAILURE AND WHICH ARE INTENDED TO ADMINISTER CPAP OR POSITIVE PRESSURE VENTILATION FOR TREATMENT OF RESPIRATORY FAILURE, RESPIRATORY INSUFFICIENCY, OR OBSTRUCTIVE SLEEP APNEA. IT PROVIDES A SEAL SUCH THAT POSITIVE PRESSURE FROM THE POSITIVE PRESSURE SOURCE IS DIRECTED INTO THE PATIENT'S NOSE AND MOUTH. IT IS HELD IN PLACE WITH AN ADJUSTABLE BONNET HEADGEAR. IT MAY BE CLEANED BY THE PROFESSIONAL IN THE HOSPITAL/INSTITUTIONAL ENVIRONMENT THROUGH A THERMAL HIGH-LEVEL DISINFECTION PROCESS OR A CHEMICAL HIGH LEVEL DISINFECTION PROCESS FOR MULTI-PATIENT USE. THE PERFORMAX PEDIATRIC SE TOTAL FACE MASK CONSISTS OF A FACEPLATE WITH A BONDED SILICONE SEAL FOR THE FACE. A 22 MM STANDARD ELBOW IS CONNECTED TO THE ELBOW HUB ON THE FACEPLATE. THE 22 MM ELBOW IS USED TO CONNECT A CONVENTIONAL AIR DELIVERY HOSE BETWEEN THE MASK AND THE POSITIVE AIRWAY PRESSURE SOURCE. THE BONNET HEADGEAR IS CONNECTED TO THE MASK THROUGH SLOTS IN THE UPPER PART OF THE FRAME AND CLIPS THAT ATTACH TO THE LOWER PART OF THE FRAME. THE MASK IS DESIGNED IN SUCH A WAY THAT IT CAN BE EASILY DISASSEMBLED FOR DISINFECTION OR TO REPLACE SEVERAL OF THE MASK COMPONENTS, SUCH AS THE HEADGEAR AND ELBOW. |
| DEVICE INTENDED PURPOSE | THE PERFORMAX PEDIATRIC SE TOTAL FACE MASK IS INTENDED TO PROVIDE A PATIENT INTERFACE FOR APPLICATION OF NONINVASIVE VENTILATION. THE MASK IS TO BE USED AS AN ACCESSORY TO VENTILATORS WHICH HAVE ADEQUATE ALARMS AND SAFETY SYSTEMS FOR VENTILATOR FAILURE, AND WHICH ARE INTENDED TO ADMINISTER CPAP OR POSITIVE PRESSURE VENTILATION FOR TREATMENT OF RESPIRATORY FAILURE, RESPIRATORY INSUFFICIENCY, OR OBSTRUCTIVE SLEEP APNEA. THE MASK IS FOR SINGLE USE/MULTIPLE USE IN THE HOSPITAL/INSTITUTIONAL ENVIRONMENT ONLY. THE MASK IS TO BE USED ON PATIENTS 1 YEAR OR OLDER (>7 KG) WHO ARE APPROPRIATE CANDIDATES FOR NONINVASIVE VENTILATION. |
| VALIDITY DATE OF REGISTRATION | 05/08/2019 - 04/08/2024 |