DEVICE DETAILS
| NAME OF DEVICE | FACE MARKS FOR VENTILATORS AND ANESTHESIA SYSTEMS |
|---|---|
| ESTABLISHMENT NAME | AMBU SALES & SERVICES SDN. BHD. |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GB2753721-73676 |
| BRAND NAME | AMBU® SILICONE FACE MASK |
| MEDICAL DEVICE CATEGORY | MD 0101 - Non-active devices for anaesthesia, emergency and intensive care |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | Ambu® Silicone Face Mask consist of a transparent dome for visual check of bleeding, vomit, and patient breathing condition. To perform safe mask ventilation, Ambu® Silicone Face Mask have a cuff that is designed to ensure a tight seal without compressing any facial nerves. The dome of the Ambu® Silicone Face Mask has an ergonomic design to ensure a good and easy hand grip. The Ambu® Silicone Face Mask 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® Silicone Face Mask and a resuscitator. |
| DEVICE INTENDED PURPOSE | Ambu® Silicone Face Masks are reusable facemasks intended for oxygenating and ventilating the airway or to direct anaesthetic gases to the upper airway. The Open Cuff Silicone Facemask are for use in hospital and pre-hospital (EMS) environments. |
| VALIDITY DATE OF REGISTRATION | 23/09/2021 - 22/09/2026 |