Description
Glucoject
Pen Needles
Insulin Pen Needles
PRODUCT IDENTIFICATION DATA
PRODUCT COMPLIANCE WITH APPLICABLE DIRECTIVES
GENERAL CHARACTERISTICS
INFORMATION ON THE REFERENCE CLASS
PACKAGES ON THE MARKET
All Glucoject Pen Needles are suitable for use with all insulin pens according to ISO 11608
Pen Needles
Insulin Pen Needles
PRODUCT IDENTIFICATION DATA
| Commercial 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 market release | 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 insulin pen needles for use in conjunction with injection pens to deliver medications into the body. Specifically, they are: - 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: 16.5mm Depth: 16.8 mm |
| Use | Glucoject® Pen Needles are sterile, single-use insulin pen needles for use in conjunction with injection pens to deliver medications (usually insulin) into the body. |
| Reuse | Glucoject® Pen Needles are sterile and single-use. Sterility is ensured 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 it is secure. Remove the outer protective cap and set it aside. You will 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 air to release a small amount of fluid. A small drop should appear at the tip of the needle. 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 point 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 therapy to offer the best results, but rotating injection sites is important to avoid side effects. It is the doctor or healthcare professional who must 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 arm. |
| Validity period | Validity is associated with the duration of sterility. Based on the tests carried out by the manufacturer HTL-STREFA SA, whose data are archived in accordance with the Quality Management System procedures, as required by the PN-EN ISO 13485 standard, a guarantee of 3 years from the date of manufacture is ensured. |
| Recommendations | - Glucoject® Pen Needles allow the administration of insulin to adults, children and obese patients. - Obese people should use longer needles than thinner people. If a thin person uses a long needle there is a risk that it will hit the muscle tissue. - In general, if a heavy person uses a short needle, the insulin may tend to smear around the injection site, causing an incorrect dosage. Pinching the skin before injecting insulin helps avoid these problems, and can be done by anyone. - 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 components | Material Components Needle/cannula AISI 302 or 304 stainless steel Polypropylene Container Needle cover Polypropylene Safety cap Polypropylene Patterned Lacquer Seal Packaging box Corrugated cardboard |
| 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 |
PACKAGES ON THE MARKET
| Product code | Repertoire Number | Commercial Name | Specifications Depth x Caliber (mm x G) | Packaging |
| 44032 | 1195790 | Glucoject Pen Needles | 10mm x 29G | 100 pcs. |
| 44033 | 1195791 | Glucoject Pen Needles | 12mm x 29G | 100 pcs. |
| 46789 | 1195782 | Glucoject Pen Needles | 5mm x 31G | 100 pcs. |
| 44030 | 1195787 | Glucoject Pen Needles | 6mm x 31G | 100 pcs. |
| 44031 | 1195789 | Glucoject Pen Needles | 8mm x 31G | 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
