
Diality, Inc.
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Moda-flx Hemodialysis System Cartridge (102121-001 ) is an FDA 510(k)-cleared medical device (K243607) manufactured by Diality, Inc.. 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 December 19, 2024. Regulation: 8.