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Glucoject
Pen Needles
Insulin pen needles
PRODUCT IDENTIFICATION DATA
PRODUCT CONFORMITY WITH APPLICABLE DIRECTIVES
GENERAL CHARACTERISTICS
REFERENCE CLASS INFORMATION
COMMERCIAL PACKAGES
All Glucoject Pen Needles can be used with all insulin pens according to ISO 11608
Pen Needles
Insulin pen needles
PRODUCT IDENTIFICATION DATA
| Trade name | Glucoject Pen Needles |
| Manufacturer | HTL-STREFA S.A., 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 launch | 2014 |
PRODUCT CONFORMITY WITH APPLICABLE DIRECTIVES
| European Directive 93/42/EEC | Compliant - CE Medical Devices (annex V + VII) |
| Classification | Class IIa |
| Notified body | DEKRA |
GENERAL CHARACTERISTICS
REFERENCE CLASS INFORMATION
| General product description | Glucoject® Pen Needles are sterile, single-use needles to be used in conjunction with injection pens for administering drugs into the body. Specifically, these are: - High quality needles - Thin-wall technology - New lubrication method - Screw-on application - 100% sterile - Six different needle versions |
| Components | - Needle - Inner protective cap - Outer protective cap - Seal |
| Features | - Extremely sharp needle tip - Triple precision bevel - Special electropolishing - Super-thin wall - Exclusive silicone lubrication |
| Technical drawing (figure 2) | 1) Needle assembly 2) Needle cover 3) Protective cap 4) Seal |
| Dimensions | Length: 29.1 mm Width: 16.5 mm Depth: 16.8 mm |
| Usage | Glucoject® Pen Needles are sterile, single-use needles for use in conjunction with injection pens for administering drugs into the body (generally insulin). |
| Reuse | Glucoject® Pen Needles are sterile and single-use. Sterility is guaranteed if the needle seal is intact. Reuse may: - cause the needle to break; - cause lipohypertrophy; - damage the sharpness or cause the tip to bend, causing bleeding, hematoma, 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 firmly in place. Remove the outer protective cap and set it aside. It will be needed later to remove the needle from the pen. Pull off the inner protective cap. 3. Set the insulin dose. 4. Check the flow by performing an air shot to release a minimal amount of liquid. A small drop should appear on the needle tip. 5. Administer the injection. 6. Replace the outer protective cap and remove the needle from the pen. |
| Insulin administration | - It is essential to choose an appropriate body site for insulin injection. - Insulin penetrates at different rates depending on the injection site. - It is recommended to inject insulin in the same area for optimal therapy results, but rotation of injection sites is important to avoid side effects. The doctor or healthcare professional should advise on the most appropriate injection site. For example: - For rapid-acting analogs and short-acting regular insulins, the abdomen is the best site. - For long-acting analogs and NPH regular insulins, the thighs are the best site. - For premixed analogs and human mixed insulins, the abdomen and arm are the best sites. |
| Shelf life | Validity is associated with the duration of sterility. Based on tests carried out by the manufacturer HTL-STREFA SA, whose data are archived in accordance with the Quality Management System procedures, as required by standard PN-EN ISO 13485, a guarantee of 3 years from the date of manufacture is assured. |
| Recommendations | - Glucoject® Pen Needles allow insulin administration to adults, children and obese patients. - Obese individuals should use longer needles than thinner people. If a thin person uses a long needle, there is a risk of hitting muscle tissue. - In general, if a heavy person uses a short needle, the insulin may tend to disperse around the injection site, thus causing incorrect dosing. Pinching the skin before injecting insulin helps avoid these problems, and can be done by anyone. - Regarding pain, a thick needle may cause more pain than a thin one, but pain perception varies widely from person to person. - In the case of high insulin doses, it is better to use a thicker needle. - It is also important to use appropriate injection technique. - Insulin release techniques vary depending on the injection site and the length of the pen needle. |
| Information on instrument components | Components Materials Needle/cannula AISI 302 or 304 stainless steel Hub Polypropylene Needle cover Polypropylene Safety cap Polypropylene Seal Patterned Lacquer Packaging box Corrugated cardboard |
| Sterilization | Gamma ray irradiation performed in accordance with PN-EN ISO 11137 |
| Further information | - Does not contain natural latex - Does not contain PVC - Does not contain phthalates |
COMMERCIAL PACKAGES
| Product Code | Repertory Number | Trade Name | Specifications Depth x Gauge (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 | 4 mm x 32 G | 100 pcs. |
All Glucoject Pen Needles can be used with all insulin pens according to ISO 11608


