6d1b5074-182d-4ac4-8676-55e3eb15c8c3UpdatePublished32023-02-062019-12-10In Commercial Distribution00606959055100PrimaryGS1BiPAP A40FRX3100S14FRX3100S14080728314Respironics, Inc.1BiPAP A40 Pro, FrancefalsefalsefalsefalsefalsefalsefalsetruefalsefalsefalsefalsetrueLabeling does not contain MRI Safety Informationtruefalse47083Portable electric ventilatorA portable, electrically-powered device intended to provide long-term alveolar support for patients who do not require complex critical care ventilation. It typically uses positive pressure to deliver gas to the lungs at normal breathing rates and tidal volumes through invasive ventilation (i.e., with an artificial airway); it may also be used non-invasively (e.g., with a mask). It includes a control system and alarms, and may include a built-in humidifier. Several methods of cycling and ventilation modes may be used. It may be line and/or internal/external battery-powered for use in the home or a healthcare facility (including ambulatory).falseActiveMNTVentilator, continuous, minimal ventilatory support, facility useStorage Environment TemperatureStorage Environment HumidityStorage Environment Temperaturefalsefalse