INSULIN PEN NEEDLE GLUCOJECT LENGTH 5 MM GAUGE 31 100 PIECES

Name: INSULIN PEN NEEDLE GLUCOJECT LENGTH 5 MM GAUGE 31 100 PIECES
Brand: A.MENARINI DIAGNOSTICS
SKU: 934512664
Price: 8.34 EUR
Availability: InStock

€8,34 EUR

€8,34 EUR ~~€23,50 EUR~~

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SKU

934512664

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Vendor

A.MENARINI DIAGNOSTICS

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Description

Glucoject
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 TO 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 to be used in conjunction with injection pens for administering medication 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
Use	Glucoject® Pen Needles are sterile, single-use needles to be used in conjunction with injection pens for administering medication into the body (generally insulin).
Reuse	Glucoject® Pen Needles are sterile and single-use. Sterility is guaranteed if the needle seal is intact. Reuse can: - cause needle breakage; - cause lipohypertrophy; - damage the sharpness or cause the tip to bend, leading to 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. 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 body site for insulin injection. - Insulin penetrates at different speeds depending on the injection site. - It is recommended to inject insulin in the same area for the therapy to yield the best 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 analogues and short-acting regular insulins, the best site is the abdomen. - For long-acting analogues and NPH regular insulins, the best site is the thighs. - For premixed analogues and mixed human insulins, the best sites are the abdomen and arm.
Shelf life	The 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 ensured.
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, insulin may tend to disperse around the injection site, thus causing an incorrect dosage. Pinching the skin before injecting insulin helps to avoid these problems, and can be done by anyone. - Regarding pain, a thick needle can 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 an appropriate injection technique. - Insulin release techniques vary depending on the injection site and the length of the pen needle.
Information on device 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
Sterilisation	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

COMMERCIALLY AVAILABLE PACKS

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 are suitable for use with all insulin pens according to ISO 11608