96190a73-bb1b-46ab-9771-576ccac9b428UpdatePublished62023-01-162016-09-21In Commercial Distribution04953170237461PrimaryGS1BALLOON CONTROL UNITOBCU711789789OLYMPUS MEDICAL SYSTEMS CORP.1"OBCU OLYMPUS BALLOON CONTROL UNIT (120V)"falsefalsefalsefalsefalsefalsefalsetruetruefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(800)401-1086xx@xx.xx46662Catheter/overtube balloon inflator, reusableA device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a reusable device.falseActiveFDAEnteroscope and accessoriesNWBEndoscope, accessories, narrow band spectrumFEDendoscopic access overtube, gastroenterology-urologyfalsefalse