Description
wellion
MEDFINE plus
DescriptionThe pen needle consists of a needle protective cap, an outer protective cap, a needle hub which can be fixed with the needle tube by the protective seal. The outer protective cap is used to maintain the sterility of the needle because the outer protective cap covers the needle cap and the needle protective cap with the protective seal on the opening hole of the outer protective cap. 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 sterile, (EO), non-toxic and non-pyrogenic, disposable fluid path. The device works on the principles of common piston syringes.
These sterile disposable insulin needles are intended for subcutaneous injection of insulin in the treatment of diabetes.
Pen needles and predicate devices have identical technological characteristics and behave the same as common piston syringes. These needles are sterilized with EO. The sterility safety level is 10-6 . They are compatible with standard pens. The product is latex-free.
Bench tests have been performed. Bench tests included biocompatibility, pen compatibility, mechanical testing, sterility testing including EO residues. Testing has shown the device to be safe, effective, and perform substantially equivalent to previously advertised devices.
Conservation
Validity with intact packaging: 60 months.
Format
Insulin pen needle.
Size: 32Gx5mm.
Cod. WELL105_32G
