MEDFINE plus

Description
The pen needle consists of a needle protective cap, an outer protective cap, a needle hub that 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 port of the outer protective cap. The hub of the needle can be connected with the pen. The needle shield is designed to provide physical protection for the needle tube. They are supplied 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 in the same way as common plunger syringes. These needles are sterilized with EO. The sterility confidence level 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 performs essentially equivalent to previous predicate devices.

storage
Validity with intact packaging: 60 months.

Format
Insulin pen needle.
Size: 32Gx5mm.

Code WELL105_32G