Belzer UW® Cold Storage Solution (BTLBUW-001)

Belzer UW® Cold Storage Solution (BTLBUW-001) is an FDA 510(k)-cleared medical device (K243384) manufactured by Bridge TO Life. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 30, 2025. Regulation: 8.