Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)

Belzer MPS® (UW Machine Perfusion Solution) is a sterile, clear to straw-colored solution for in vitro flushing and continuous hypothermic machine perfusion of explanted abdominal organs. It is supplied in single-use 1000 mL PVC-free bags and is intended for use by trained medical healthcare staff during organ procurement and transplantation procedures.

The device has identical chemical composition, osmolality (300 mOsmol/kg), and pH (approximately 7.4 at 20°C) as the predicate MaPerSol® Solution. Both are supplied in 1000 mL single-use PVC-free bags with integrated ports for delivery and component addition. The subject device uses 0.2 µ and two 0.1 µ membrane filtrations for sterility assurance; the predicate uses 0.1 µ membrane filtration. Both are non-pyrogenic and biocompatible per ISO 10993-1/2/5/10/12.

ISO 10993-1/2/5/10/12 (biocompatibility testing). The document also references USP monograph for 0.9% Sodium Chloride Irrigation.

Belzer MPS® is substantially equivalent to MaPerSol® because they have identical chemical composition (same 12 active components in identical concentrations), identical intended use (flushing and continuous hypothermic perfusion of explanted organs), identical osmolality and pH, and equivalent sterility/safety profiles. Both devices perform the same organ preservation function through the same mechanism—maintaining hypothermia via cold solution contact with organ vasculature during recovery, storage, and transport. The only material difference noted is a more stringent filtration method for Belzer MPS® (0.2 µ plus two 0.1 µ versus one 0.1 µ), which enhances rather than alters safety.