510(k) K250459

DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution by Technoflex Sas. — Product Code KPE

K250459 is an FDA 510(k) premarket notification submitted by Technoflex Sas. for the device "DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution". The FDA issued a decision of Substantially Equivalent on April 18, 2025. The device falls under product code KPE (Container, I.V.), a Class II device regulated under 21 CFR 880.5025.