34b42d32-3f46-4aa5-9301-5ff8b49fc073UpdatePublished42021-01-252016-04-212021-01-24Not in Commercial Distribution08774660000749PrimaryGS1TransonicHQC6XL101317451TRANSONIC SYSTEMS INC.1falsefalsefalsefalsefalsefalsefalsetruetruefalsefalsefalsefalseLabeling does not contain MRI Safety InformationfalsefalseK87204800061227Invasive vascular ultrasound systemA mains electricity (AC-powered) device assembly designed to invasively locate and assess the extent of vascular flow restriction (e.g., clots, stenosis, mechanical damage) using ultrasound/Doppler/transit time technology during procedures involving vascular surgery. It may also provide additional measurements (e.g., blood pressure, vascular resistance). It consists of a mobile (on wheels) control unit with graphical user-interface, typically placed outside the sterile field; and an attached, reusable, sterilizable probe intended to be used within the body (invasive) but not within the lumen of the blood vessel. This is a reusable device.falseActiveDPWFlowmeter, Blood, CardiovascularfalsetrueEthylene Oxide