Fluido® AirGuard System

The Fluido® AirGuard System is a pressurized infusion system that warms blood and fluids using infrared heating technology before administration to patients. It is designed to prevent perioperative hypothermia and enable rapid volume replacement in high blood loss surgical procedures and trauma situations.

The device uses non-contact infrared heating (versus the predicate's electromagnetic inductive heating) to warm crystalloid, colloid, or blood products including packed red blood cells. It incorporates an air detection system (AirGuard) to prevent air embolism, achieves maximum flow rates of 400 mL/min for standard sets and 900 mL/min for trauma sets, operates at 300 mmHg maximum pressure, and includes temperature monitoring with audible and visual alarms.

Biocompatibility per ISO 10993 and USP; sterilization validation per ISO 11135; EMC testing per IEC 60601-1-2; electrical safety per ANSI/AAMI ES60601-1; software lifecycle per IEC 62304; human factors validation per FDA guidance and IEC 62366; hemocompatibility testing; bench performance per ASTM F2172-02; flow rate testing per ISO 8536-4; and transport testing per ISTA 3A.

The FAS shares the same intended use (rapid infusion of warmed blood/fluids for trauma and high blood loss surgery), regulatory classification (Class II infusion pump), and principle of operation (non-contact dry heating with in-line warming) as the Belmont Rapid Infuser RI2 predicate. Although the FAS uses infrared heating versus the predicate's inductive heating, both methods achieve substantially equivalent functional outcomes. Comparative testing demonstrated equivalent warm-up times, output temperatures, maximum flow speeds, temperature alarms, air removal capability, and pressure regulation, supporting substantial equivalence despite the heating technology difference.