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510(k) Data Aggregation
K Number
K210749Device Name
Empty EVA Bag
Manufacturer
Haemotronic S.p.a.
Date Cleared
2021-08-19
(160 days)
Product Code
KPE, PAN
Regulation Number
880.5025Why did this record match?
Applicant Name (Manufacturer) :
Haemotronic S.p.a.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Empty EVA Bag is an empty container used for administration of solutions to the patients using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique.
Device Description
The product is an empty flexible container (bag) in plastic material, that is to be filled before use, intended for the administration of intravenous infusion solutions), and provided sterile. It is provided in two different configurations, with three tubes or one tube:
- bag with 3 tubes: The empty bag is filled by connecting it to containers (generally glass bottles) filled with the solutions to be administered. The filling is done through the tube with the big bore connector where the non- re-opening clamp is located; this tube is closed with a screwed cap (air-tight closure). After filling, the bag is clamped by means of the non-re-opening clamp and closed with the sealing cap (screwed cap), to secure 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 access port (spike port). When the bag is filled, other drugs can be added using the second access port (injection port). The device is available in multiple containment volumes ranging from 250mL to 5000mL.
- bag with 1 tube: the bag is provided with one tube used both for the filling of the bag and the administration of the solution to the patient. The tube is closed with a screwed male Luer cap (air-tight closure). The filling is done by connecting the female Luer connector of the tube to the containers filled with the solutions to be administered. After filling, the bag is clamped by means of a pinch clamp and closed with the sealing cap (screwed cap), to secure the contents prior to administration. To make the fluid outflow from the bag towards the patient, the bag is connected to an intravascular administration line via the same female Luer connector. It is available in multiple containment volumes of 50mL, 100mL, and 250mL.
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