190e22b3-2c6c-4f5f-a400-16e64c7930c8UpdatePublished32018-07-062017-11-13In Commercial DistributionB140MP8U0PrimaryHIBCCBRAEBON MediByte MP8MP8251731105Braebon Medical Corporation1The MediByte is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at home or in a clinical environment. This unit has a generic USB cable. falsefalsefalsefalsefalsefalsefalsetruetruefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse613.831.6690info@braebon.comK06176400033843PolysomnographA mains electricity (AC-powered) device designed to record physiological signals from a sleeping patient to assess sleep disorders (e.g., insomnia, snoring or sleep apnoea). The device is typically computerized and usually records an electrocardiogram (ECG), electroencephalogram (EEG), chest wall motion, airflow at both the nose and the mouth, eye movements, haemoglobin oxygen saturation (SpO2) and electromyogram (EMG). Parameters may be added or omitted depending on the study being performed. The device includes multiple electrodes/sensors placed on the patient in specific areas as well as amplifiers and filters for recording.falseActiveMNRVentilatory Effort RecorderStorage Environment HumidityStorage Environment Temperaturefalsefalse