Device Dossier
Basic intravenous administration set
Device Dossier for Basic intravenous administration set (Basic intravenous administration set, Class IIa, sponsor Regional Health Care Group). ARTG…
- GMDN category: Basic intravenous administration set
Intended purpose
This device is a contrast administration set line, delivering contrast medium to the patient. It is a disposable device to be used as part of the CT Expres system. The CT Expres Contrast Media Delivery System is indicated for controlled automatic venous-side administration of contrast media to human subjects while undergoing examination by means of a computed tomography (CT) scanner, including CT angiography (CTA). This device is not intended for injection of contrast media for coronary arteriography, or for any other use for which the device is not indicated.