MedNet, a medical technology service provider and supplier, is expanding its portfolio of non-sterile CE-marked components with a range of medical high-pressure lines and pressure monitoring lines to meet the special requirements of kit packers and to simplify the handling of regulatory challenges.
For kit packers, the non-sterile CE-marked lines aim to offer two advantages:
(1) Kit packers benefit from the fact that the CE marking of the lines does not require the conformity assessment in terms of its entirety. The technical documentation is also the responsibility of the component supplier.
(2) Non-sterile components eliminate the need for time-consuming repackaging of any sterile alternatives. In addition, non-sterile components allow for single-use sterilisation, thereby avoiding regulatory and qualitative risks. Last but not least, kit packers benefit from the lower price of non-sterile products compared to sterile components.
Ole Stein, managing director of MedNet, said: “Our CE-marked non-sterile components save kit packers a lot of regulatory effort, time and costs.”
The high-pressure lines (1200 psi) have been specially developed for cardiology and radiology requirements and are used, for example, for the passage of contrast media and sodium chloride solutions. They are made of DEHP-free PVC or alternatively, fabric- reinforced PUR and are equipped with a female luer lock connector and optionally, with a male luer lock connector or a rotating adapter.
The pressure monitoring lines (500 psi) can be used for magnetic resonance imaging (MRI), computed tomography (CT) and phlebograph applications, e.g., for the injection of contrast media or a sodium chloride solution. They also provide pressure measurement and are made of DEHP-free, transparent PVC. The lines are equipped with a female and male luer lock connector. Variants with two male connectors are also available as an option.
All high pressure and pressure monitoring lines are available in lengths from 15cm to 250cm and are supplied with end caps.
In addition to high pressure lines and pressure monitoring lines, MedNet offers a wide range of other non-sterile CE-marked components (e.g. introducers, syringes, needles, valves and valve banks).
