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…
- GMDN category: Infusion pump, general-purpose
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.