DEVICE DETAILS
| NAME OF DEVICE | FACE MASKS FOR VENTILATORS AND ANESTHESIA SYSTEMS |
|---|---|
| ESTABLISHMENT NAME | AMBU SALES & SERVICES SDN. BHD. |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GB2586021-74852 |
| BRAND NAME | AMBU® KING MASK |
| MEDICAL DEVICE CATEGORY | MD 0101 - Non-active devices for anaesthesia, emergency and intensive care |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | Ambu® King Mask consist of a transparent dome for visual check of bleeding, vomit, and patient breathing condition. To perform safe mask ventilation, Ambu® King Mask have a cuff that is designed to ensure a tight seal without compressing any facial nerves. The dome of the Ambu® King Mask has an ergonomic design to ensure a good and easy hand grip. The Ambu® King Masks can be used in a situation of high-pressure ventilation and are available in different sizes. Facemask ventilation can be performed using either a single hand or a two hand ventilation technique allowing for oxygenation and ventilation of patients until a more definitive airway can be established and in cases where endotracheal intubation or other definitive control of the airway is not possible. In an unconscious patient an oropharyngeal airway can be inserted in order to prevent the tongue from covering the epiglottis. An oropharyngeal airway can be used together with Ambu® King Mask and a resuscitator. |
| DEVICE INTENDED PURPOSE | Ambu® King Mask are intended to direct anaesthesia or other medical gases into the patient’s upper airway without introducing any apparatus into the trachea. The King Masks are in connection with a breathing circuit apparatus (anaesthetic circuit, manual resuscitators, automatic resuscitators and ventilators), covering the patient’s mouth and nose during anaesthesia, or medical gas inhalation. The King Masks are single patient use disposables. For use by CPR trained personnel only. |
| VALIDITY DATE OF REGISTRATION | 23/09/2021 - 22/09/2026 |