Belzer UW® Cold Storage Solution (BTLBUW-001)

Belzer UW® Cold Storage Solution (BTLBUW-001) is a sterile, non-pyrogenic solution used for hypothermic flushing and cold storage of kidney, liver, and pancreas organs at the time of organ removal from donors in preparation for storage, transportation, and transplantation. The solution is not indicated for continuous machine perfusion and is supplied in 500 mL, 1 L, and 2 L non-PVC bags for single use only.

The subject device has identical composition, osmolarity (320 mOsmol/kg), sodium concentration (29 mEq/L), potassium concentration (125 mEq/L), pH (approximately 7.4 at 20°C), storage temperature (2°-25°C), sterilization method (aseptic fill), and primary container material (EVA) as the predicate device CoStorSol®. The subject device offers additional size options (500 mL, 1 L, 2 L versus predicate's 1 L only) and has a 6-month shelf life compared to the predicate's 24 months.

Biocompatibility testing was performed in accordance with ISO 10993-1/2/5/10/12. Sterility is assured via 0.2 µm and two 0.1 µm membrane filtration. The device is non-pyrogenic and aseptically filled.

Bridge to Life's Belzer UW® Cold Storage Solution is substantially equivalent to CoStorSol® Solution because both devices share identical composition at every ingredient level, the same osmolarity and electrolyte concentrations, identical pH, the same intended use for organ preservation, equivalent biocompatibility per ISO standards, and equivalent sterilization and container materials. Both are Class II devices regulated under 21 CFR 876.5880 for isolated kidney perfusion and transport systems, and the non-clinical data demonstrates the subject device performs safely and effectively identically to the predicate.