DEVICE DETAILS
| NAME OF DEVICE | DRAEGER LITESTAR DISPOSABLE FACE MASK |
|---|---|
| ESTABLISHMENT NAME | DRAEGER MALAYSIA SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GB1423822-82734 |
| BRAND NAME | DRAEGER |
| MEDICAL DEVICE CATEGORY | MD 0101 - Non-active devices for anaesthesia, emergency and intensive care |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | Anesthesia masks are accessories of anesthesia devices. They support the application of medical gases in the patient´s upper airway without the need to insert any additional devices in the trachea. Anesthesia masks are in direct contact with the patient face and breathing gas. The application of the anaesthesia masks occurs under direct human supervision. LiteStar anaesthesia face mask is disposable as well. The teardrop shape of the mask supports an anatomical fit. The transparent mask body allows for continuous observation of the patient’s conditions. The reinforcing ring placed around the mask connector provides stable connection with breathing circuit systems. There is a new generation of LiteStar masks. The new portfolio was extended to another size (size 7) and the design was optimized. An easy application is supported by additional mask accessories: hook rings and headgears for fixation. Two different headgears in small and large designs offer patients and physicians a soft and elastic fixation. |
| DEVICE INTENDED PURPOSE | Disposable anesthesia mask for the application of medical gases in the patient’s upper airways without the need to insert any additional devices in the trachea. |
| VALIDITY DATE OF REGISTRATION | 30/12/2021 - 29/12/2026 |