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Diabetes and blood sugar - blood sugar devices Glucoject needle pen 5mm g31 Glucoject
Glucoject
Pen Needles
Needles for insulin pens
PRODUCT IDENTIFICATION
CONFORMATION OF PRODUCT AT APPLICABLE DIRECTIVES
GENERAL FEATURES
INFORMATION ON THE REFERENCE CLASS
CONFECT IN COMMERCE
All Glucoject Pen Needles can be used with all insulin pens according to ISO 11608
Pen Needles
Needles for insulin pens
PRODUCT IDENTIFICATION
Commercial 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 |
Code CND | A010199 - Insulin Pen Needles |
Year of marketing | 2014 |
CONFORMATION OF PRODUCT AT APPLICABLE DIRECTIVES
European Directive 93/42/EEC | Conforms - CE Medical devices (annex V + VII) |
Classification | Class II |
Notified body | DEKRA |
GENERAL FEATURES
INFORMATION ON THE REFERENCE CLASS
General description of the product | Glucoject® Pen Needles insulin pen needles are sterile, disposable to be used in combination with injection pens for drug administration in the body. Specifically, these are: - High quality needles - Thin wall technology - New lubrication method - Screwing application - 100% sterili - Six different versions of needle |
Components | - Ago - Internal protective cap - External protective cap - Seal |
Description | - Extremely sharp needle tip - Triple precision bevelling - Special electrolucidation - Super-thin wall - Exclusive silicone lubrication |
Technical drawing (Figure 2) | 1) needle complex 2) Needle covers 3) Protective hood 4) Seal |
Dimensions | Length: 29.1 mm Width: 16,5 mm Depth: 16.8 mm |
Use | Glucoject® Pen Needles insulin pen needles are sterile, disposable to be used in combination with injection pens for the administration of drugs in the body (usually insulin). |
Reuse | Glucoject® Pen Needles insulin pen needles are sterile and disposable. The sterility is guaranteed if the needle seal is intact. Reuse can: - cause needle breaking; - cause lipoipertrophy; - damaging the sharpening or may cause the bending of the tip, causing bleeding, hematoma or scarring; - increase the risk of needle breakage in the skin; - increase the risk of infections as the needle is no longer sterile. |
Method of use and action mechanism (Figure 3) | 1. Remove the seal from the needle. 2. Place the right needle on the pen and screw it until it is firm. Remove the external protective cap and clean it aside. It will be later to remove the needle from the pen. Pull away the inside protective cap. 3. Set insulin dose. 4. Check the flow by running a puncture in the air to get a minimum amount of liquid out. On the tip of the needle should appear a small drop. 5. Run the injection. 6. Reposition the external protective cap and remove the needle from the pen. |
Insulin administration | - It is essential to choose a suitable point of the body where to inject insulin. - Insulin penetrates at different speeds depending on the injection point. - It is recommended to inject insulin in the same area so that the therapy offers the best results, but the rotation of injection points is important to avoid side effects. It is the doctor or health care professional who should recommend the most appropriate injection point. For example: - For fast-acting analogs and short-acting normal insulines the best place is the abdomen. - For protracted action analogs and for normal NPH insulines the best place is thighs. - For premixed analogues and for mixed human insulines the best places are abdomen and arm. |
Validity period | Validity is associated with the duration of sterility. According to the tests carried out by the manufacturer HTL-STREFA SA, whose data is stored in accordance with the Quality Management System procedures, as required by the PN-EN ISO 13485, a 3-year warranty is ensured from the manufacturing date. |
Recommendations | - Glucoject® pen needles Pen Needles allows insulin administration to adults, children and obese patients. - The obese should use longer needles than the leaner. If a lean person uses a long needle there is a risk that affects muscle tissue. - In general, if a heavy person uses a short needle insulin may tend to disperse around the injection point, thus causing an incorrect dosage. Grab the skin pinched before injecting the insulin helps to avoid these problems, and can be done by anyone. - As for pain, a needle can often cause more pain than a subtle one, but the perception of pain varies widely from person to person. - In case of high doses of insulin it is better to use a needle more often. - It is also important to use an appropriate injection technique. - Insulin release techniques vary depending on the injection point and the length of the pen needle. |
Information about instrument components | Components Materials Ago/cannula AISI 302 or 304 stainless steel Polypropylene container Polypropylene needle covers Safety cap Polypropylene Seillo Patterned Lacquer Packing box Corrugated cardboard |
Sterilization | Irradiation with gamma rays performed in accordance with PN-EN ISO 11137 |
More information | - Does not contain natural latex - It does not contain PVC - It does not contain phthalates |
CONFECT IN COMMERCE
Product code | Number of Directory | Commercial name | Specifications 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 | 4 mm x 32 G | 100 pcs. |
All Glucoject Pen Needles can be used with all insulin pens according to ISO 11608
- Deductible product
- Yes
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