40e6dcf8-6477-4d9f-9c33-889218531121UpdatePublished52021-04-072016-09-12In Commercial Distribution10840935102403PrimaryGS1Orbit98-0123-03148191133SUNTECH MEDICAL, INC.1falsefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1-919-654-2300UDI_MAIL@suntechmed.comK01062200036888Blood pressure ambulatory recorderAn electrically-powered, noninvasive device designed to be worn by a patient (typically on the arm or wrist) during daily activities for 24-hour recording of blood pressure; it is not intended to detect cardiac arrythmias. The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. The device typically incorporates display and controls and may include a cuff with connection tubing and/or calibration device.falseActiveDXNSystem, Measurement, Blood-Pressure, Non-Invasivefalsefalse