wellion

MEDFINE plus

Description
The pen needle consists of a needle protective cap, an outer protective cap, and a needle hub that can be secured to the needle tube with a protective seal. The outer protective cap serves to maintain the needle's sterility by covering the needle cap with the outer protective cap, and the needle protective cap with the protective seal over the opening of the outer protective cap. The needle hub can be connected to the pen. The needle protective cap 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 operates on the principles of common piston-operated syringes.
These sterile disposable insulin needles are intended for subcutaneous injection of insulin in the treatment of diabetes.
Pen needles and related devices have identical technological characteristics and behave similarly to common piston syringes. These needles are sterilized with EO. The sterility assurance level is 10-6. They are compatible with standard pens. The product is latex-free.
Benchtop testing was performed. Benchtop testing included biocompatibility, pen compatibility, mechanical testing, and sterility testing, including EO residues. The tests demonstrated that the device is safe, effective, and performs substantially equivalently to previously recommended devices.

Conservation
Shelf life when packaged intact: 60 months.

Format
Insulin pen needle.
Size: 32Gx5mm.

Cod. WELL105_32G