Glucoject Pen Needles Insulin pen needles PRODUCT IDENTIFICATION DATA Trade name Glucoject Pen Needles Manufacturer HTL-STREFA SA, 95-035 Ozorkòw, 7 Adamòwek St., Poland. Distributor A.Menarini Diagnostics Florence - Italy Internal Codes 44029-44030-44031-44032-44033-46789 CND Code A010199 - Insulin Pen Needles Year of placing on the market 2014 PRODUCT COMPLIANCE WITH APPLICABLE DIRECTIVES European Directive 93/42/EEC Compliant - CE Medical Devices (annex V + VII) Classification Class IIa Notified body DEKRA GENERAL CHARACTERISTICS INFORMATION ON THE REFERENCE CLASS General product description Glucoject® Pen Needles are sterile, single-use needles intended for use with insulin pens to administer medications into the body. Specifically, they include: - High quality needles - Thin-wall technology - New lubrication method - Screw application - 100% sterile - Six different needle versions Components - Needle - Internal protective hood - External protective hood - Seal Characteristics - Extremely sharp needle tip - Triple precision bevel - Special electropolishing - Super thin wall - Exclusive silicone lubrication Technical drawing (figure 2) 1) Needle complex 2) Needle cover 3) Protective hood 4) Seal Dimensions Length: 29.1 mm Width: 16.5 mm Depth: 16.8 mm Use Glucoject® Pen Needles are sterile, single-use insulin pen needles intended for use in conjunction with injection pens to deliver medications (usually insulin) into the body. Reuse Glucoject® Pen Needles are sterile and disposable. Sterility is guaranteed if the needle seal is intact. Reuse can: - cause the needle to break; - cause lipohypertrophy; - damage the sharpness or may cause the tip to bend, resulting in bleeding, bruising or scarring; - increase the risk of needle breakage in the skin; - increase the risk of infection as the needle is no longer sterile. Method of use and mechanism of action (figure 3) 1. Remove the seal from the needle. 2. Place the needle straight onto the pen and screw it on until its secure. Remove the outer protective cap and set it aside. Youll need it later to remove the needle from the pen. Pull off the inner protective cap. 3. Set the insulin dose. 4. Check the flow by pricking the needle in the air to release a small amount of fluid. A small drop should appear at the needle tip. 5. Perform the injection. 6. Replace the outer protective cap and remove the needle from the pen. Insulin administration - It is essential to choose an appropriate site on the body where to inject insulin. - Insulin penetrates at different rates depending on the injection site. - It is recommended to inject insulin in the same area for the best results, but rotating injection sites is important to avoid side effects. Your doctor or healthcare professional should recommend the most appropriate injection site. For example: - For rapid-acting analogues and short-acting regular insulins, the best place is the abdomen. - For long-acting analogues and regular NPH insulins, the best place is the thighs. - For premixed analogues and mixed human insulins, the best places are the abdomen and upper arm. Validity period Shelf life is associated with the duration of sterility. Based on tests conducted by the manufacturer HTL-STREFA SA, whose data is archived in accordance with the Quality Management System procedures required by the PN-EN ISO 13485 standard, a warranty of 3 years from the date of manufacture is guaranteed. Recommendations - Glucoject® Pen Needles allow the administration of insulin to adults, children and obese patients. - Obese people should use longer needles than leaner people. If a lean person uses a long needle, theres a risk of injuring muscle tissue. - Generally, if a heavy person uses a short needle, the insulin may tend to leak around the injection site, thus causing an incorrect dosage. Pinching the skin before injecting helps avoid these problems, and anyone can do it. - As for pain, a thick needle can cause more pain than a thin one, but the perception of pain varies greatly from person to person. - In case of high doses of insulin it is better to use a thicker needle. - It is also important to use an appropriate injection technique. - Insulin delivery techniques vary depending on the injection site and the length of the pen needle. Information about the instrument componentsMaterialComponents Needle/cannula AISI 302 or 304 stainless steel Polypropylene container Polypropylene needle cover Safety cap Polypropylene Patterned Lacquer Seal Corrugated cardboard packaging box Sterilization Gamma irradiation performed in accordance with PN-EN ISO 11137 Learn more - Does not contain natural latex - Does not contain PVC - Does not contain phthalates COMMERCIAL PACKAGING Product codeRepertoire NumberCommercial NameSpecifications Depth x Caliber (mm x G)Packaging 44032 1195790 Glucoject Pen Needles 10 mm x 29 G 100 pcs. 44033 1195791 Glucoject Pen Needles 12 mm x 29 G 100 pcs. 46789 1195782 Glucoject Pen Needles 5 mm x 31 G 100 pcs. 44030 1195787 Glucoject Pen Needles 6 mm x 31 G 100 pcs. 44031 1195789 Glucoject Pen Needles 8 mm x 31 G 100 pcs. 44029 1195734 Glucoject Pen Needles 4mm x 32G 100 pcs. All Glucoject Pen Needles are suitable for use with all insulin pens according to ISO 11608