Descrizione Clinica
wellion
MEDFINE plus
DescriptionThe needle of the pen consists of a protective needle cap, an external protective cap, a needle hub that can be fixed with the needle tube through the protective seal. The external protective cap serves to maintain needle sterility because the external protective cap covers the needle cap and the needle protective cap with the protective seal on the outer protective cap opening hole. The needle hub can be connected with the pen. The needle protective cap is designed to provide physical protection to the needle tube. They are provided with a path of sterile fluid, (EO), non-toxic and non-pyrogen, disposable. The device works on the principles of common piston syringes.
These disposable needles for sterile insulin are intended for insulin subcutaneous injection in the treatment of diabetes.
Pen needles and preached devices have identical technological features and behave in the same way as common piston syringes. These needles are sterilized with EO. The level of safety of sterility is 10-6 . They are compatible with standard pens. The product is latex free.
Bench tests were performed. Bench tests included biocompatibility, pen compatibility, mechanical tests, sterility tests including EO residues. Tests have shown that the device is safe, effective and works substantially equivalent to previous devices.
Conservation
Validity of whole packaging: 60 months.
Format
Pen needle for insulin.
Size: 32Gx5 mm.
Cod. IN THE CASE OF VEHICLES OF CATEGORIES M1 AND N2