RemunityPRO™ Pump for Remodulin® (treprostinil) Injection

RemunityPRO™ Pump for Remodulin® (treprostinil) Injection is an FDA 510(k)-cleared medical device (K250357) manufactured by Deka Research & Development Corp.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 10, 2025. Regulation: 8.