DEVICE DETAILS
| NAME OF DEVICE | DRAEGER FULL FACE MASK NON-INVASIVE VENTILATION FACE MASKS |
|---|---|
| ESTABLISHMENT NAME | DRAEGER MALAYSIA SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GB7642222-99649 |
| BRAND NAME | DRAEGER |
| MEDICAL DEVICE CATEGORY | MD 0101 - Non-active devices for anaesthesia, emergency and intensive care |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | The mask is designed for noninvasive ventilation therapy. As the mask covers nose and mouth, it provides an effective therapy, even in case of mouth breathing. |
| DEVICE INTENDED PURPOSE | ClassicStar The ClassicStar NIV nasal masks and ClassicStar plus NIV nasal masks, non-vented or vented, are intended to provide a patient interface for adult patients (>30 kg/66 lb) who are appropriate candidates for non-invasive ventilation in hospital environments. The masks are intended to be used as accessories to ventilators that have appropriate alarms and safety systems for ventilator failure. The masks are intended to administer CPAP (Continuous Positive Airway Pressure/spontaneous breathing with continuous positive airway pressure) or mechanical ventilation for treatment of respiratory insufficiency/disorder. The NIV nasal masks are disposable masks for single-patient use. The ClassicStar NIV oronasal masks are intended as patient interface for adults (>30 kg/66 lb) who are appropriate candidates for non-invasive ventilation in hospital environments, also during transport, or in vehicles, helicopters, and airplanes during emergency situations. The NIV oronasal masks are disposable masks for single-patient use. ClassicStar NIV total-face mask with standard elbow (SE) The NIV total-face mask ClassicStar SE, non-invasive ventilation (NIV), with standard elbow (SE), is intended to provide a patient interface for application of non-invasive ventilation. The NIV total-face mask is to be used as an accessory to ventilators that have appropriate alarms and safety systems for ventilator failure and which are intended to administer continuous positive airway pressure (CPAP) or positive pressure ventilation for treatment of respiratory failure or respiratory insufficiency. It is intended for application on adults (>30 kg/66 lbs) who are appropriate candidates for non-invasive ventilation in hospital or institutional environments. The ClassicStar NIV total-face masks are for single-patient use. ClassicStar NIV total-face mask with anti-asphyxia valve (AAV) The NIV total-face mask ClassicStar AAV, non-invasive ventilation (NIV), with anti-asphyxia valve (AAV), is intended to be used with positive airway pressure devices (PAP devices), operating at or above 3 hPa (3 cmH2O). The NIV total-face mask has exhalation ports and therefore does not require the use of a separate exhalation device. It is intended for application on adults (>30 kg/66 lbs) who are appropriate candidates for non-invasive ventilation in hospital or institutional environments. ClassicStar NIV total-face mask with anti-asphyxia valve (AAV) without exhalation ports (EP) The NIV total-face mask ClassicStar AAV without EP, non-invasive ventilation (NIV), with anti-asphyxia valve (AAV) and without exhalation ports (EP), is intended to be used with positive airway pressure devices (PAP devices), operating at or above 3 hPa (3 cmH2O). The NIV total-face mask has no exhalation ports and therefore the connection of an external exhalation system is absolutely required. It is intended for application on adults (>30 kg/66 lbs) who are appropriate candidates for non-invasive ventilation in hospital or institutional environments. The ClassicStar NIV total-face masks are for single-patient use. NovaStar The NovaStar NIV oronasal mask can be used multiple times on multiple patients. Reuse, however, is limited to a maximum of 5 times. It is intended for application on adults (>30 kg/66 lb) who are appropriate candidates for non-invasive ventilation in hospital environments. NovaStar plus SE The NovaStar plus NIV oronasal mask with standard elbow (SE) is intended to provide a patient interface for the application of non-invasive ventilation. The mask is intended to be used as accessory to ventilators that have appropriate alarms and safety systems for ventilator failure. The mask is intended to administer CPAP (Continuous Positive Airway Pressure/spontaneous breathing with continuous positive airway pressure) or mechanical ventilation for treatment of respiratory failure or respiratory insufficiency. NovaStar plus AAV The NovaStar plus NIV oronasal mask with anti-asphyxia valve (AAV) is intended to be used with positive airway pressure devices (PAP devices) operating at or above 3 hPa (3 cmH2O). The mask has exhalation ports and therefore does not require the use. If a separate exhalation device. NovaStar plus AAV without EP The NovaStar plus NIV oronasal mask with anti-asphyxia valve (AAV) without EP is intended to be used with positive airway pressure devices (PAP devices) operating at or above 3 hPa (3 cmH2O). The mask has no exhalation ports and therefore the connection of an external exhalation device is absolutely required. Because the family of masks used with different accessories end up in different design, causing the use of the masks has slight difference. Please refer to the Intended use in the Annex E IFU and Intended use document. |
| VALIDITY DATE OF REGISTRATION | 27/07/2022 - 26/07/2027 |