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510(k) Data Aggregation
K Number
K250459Device Name
DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution
Manufacturer
Technoflex SAS.
Date Cleared
2025-04-18
(59 days)
Product Code
KPE
Regulation Number
880.5025Why did this record match?
Applicant Name (Manufacturer) :
Technoflex SAS.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TECHNOFLEX DMRX Empty solution container is empty container used for administration of intravenous solutions to the patient using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique. After use the bag is discarded.
Device Description
The subject device DMRX Empty Solution Container are IV bags for hospital use which consist of two tubes necessary for the filling of the bag itself and the administration of the solution to the patient. a) fill port to fill the container/injection port for additions of other medications and; b) a spike port to connect an intravascular administration set to the bag to dispense medication. One port is an injection port, which will be used for filling the bag with the solution. The filling will be made with a needle, using aseptic technics by a laboratory personnel or pharmacist. The elastomeric plug is auto sealable and does not require a cap after filling. The administration will be performed by nurses or personnel appropriately trained. They will connect an administration set to the second port which is a twist-off port (spike port). The device is an empty flexible container (bag) made of PP (Polypropylene), SEBS (Styrene Butadiene Copolymer), Thermoplastic Elastomer, PC (Polycarbonate), and Polyisoprene with silicone. One port is an injection port. The empty bag is filled by connecting a needle into the injection port. Using aseptic technics by a trained laboratory personnel or pharmacist, the filling is done by the tube with the injection port connector. After filling, the bag remains closed due to the self-sealing plug which secures the contents prior to administration. To make the fluid outflow from the bag towards the patient, the bag is connected to an intravascular administration set via the second port (spike port). When the bag is already filled, other medications can be added using the injection port. The device will be available in four containment volumes (100mL, 250mL, 500mL, and 1000mL). Bags are double packed and proposed sterilized with e beam radiation.
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