°M Warmer System with °M Station

The °M Warmer System with °M Station is an in-line fluid warmer that heats blood, blood products, colloids, and crystalloid solutions to approximately 39°C before infusion to prevent hypothermia. It is intended for use by healthcare professionals in hospitals, clinics, and ground-based ambulances during medical emergencies or surgical procedures requiring warm fluid administration.

The subject device adds a new °M Station (AC mains power supply) to the existing °M Warmer System, which previously relied on a rechargeable battery pack. Both use software-controlled resistive heating with a sterile fluid path of parylene-coated aluminum, deliver up to 150 ml/min, maintain 39±3°C output at 5°C input, and include dual redundant temperature sensors with visual LED alarms.

IEC 60601-1 Edition 3.2 (general medical electrical equipment safety), IEC 60601-1-2 Edition 4.1 (electromagnetic compatibility), IEC 60601-1-12 Edition 1.1 (emergency medical services environment), and ASTM 2172:2002 (blood/intravenous fluid irrigation fluid warmers).

The °M Warmer System with °M Station is substantially equivalent to the predicate °M Warmer System (K232107) because both are portable IV fluid warming systems with identical performance specifications, heating technology, fluid path materials, and user interface. The addition of AC mains power as an alternative to the rechargeable battery does not raise different safety or effectiveness questions and is supported by equivalent electrical safety and EMC testing.