Device Dossier

Infusion pump, general-purpose

Device Dossier for Infusion pump, general-purpose (Infusion pump, general-purpose, Class IIb, sponsor Imaxeon). ARTG record, intended purpose, GMDN…

Intended purpose

The MRidium 3860+ MRI Infusion Pump/Monitoring System is intended for general hospital or clinical use by medical professionals whenever it is required to infuse patients with subcutaneous, intra-venous, or intra-arterial fluids before, during, or after Magnetic Resonance Imaging (MRI) scans, functioning while either in a stationary or mobile position. The system is useful in the administration of fluids requiring precisely controlled infusion rates. The system can operate in either continuous, intermittent, or bolus delivery mode.

TGA Public Summary