4SURE Pen Needles Datasheet

Product catalog summary

Product Compliance
The pen needles comply with CE 0197, Class IIa Medical Devices, MDD 93/42/EEC, and adhere to ISO standards 9692, 11608-2, and 13485.

Manufacturing Details
The legal manufacturer is Promisemed Medical Devices Inc., located in Canada.

Sterilization and Shelf Life
The needles are sterilized using Ethylene oxide (EtO) and have a maximum shelf life of 58 months.

Materials Used
The pen needles feature thin wall technology, double silicone coating, and an ultra-sharp tip. They are made from electro-polished stainless steel with a silicone oil coating, and other components include polyethylene and polypropylene.

Product Range Overview
The product range includes various sizes with lengths of 4 mm, 5 mm, 6 mm, and 8 mm, and diameters of 31 G (0.25 mm) and 32 G (0.23 mm).

Packaging Details
Each individual box contains 100 units, and an outer box contains 50 individual boxes, totaling 5000 units. The packaging is available in five languages: English, French, German, Spanish, and Italian.

Storage Conditions
Store the needles upright in a clean, dry place, away from sunlight, rain, and moisture. Do not exceed temperatures of 40°C or moisture over 80%.

Company Information
Nipro Diabetes Care is part of Nipro Corporation Japan, a global healthcare company. They provide high-quality products for diabetes care, including meters, test strips, pen needles, and lancets.

Catalog excerpts

DIABETES CARE PRODUCT DATA SHEET STERILE SINGLE-USE PEN INJECTOR NEEDLES INTENDED FOR THE DELIVERY OF INSULIN

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• Thin wall technology • Double silicone coating • Ultra sharp tip PRODUCT COMPLIANCE • CE 0197, Class IIa Medical Devices, MDD 93/42/EEC MANUFACTURING DETAILS Legal manufacturer: Promisemed Medical Devices Inc., CANADA STERILIZATION AND SHELF LIFE Sterilization Single-use only Maximum Shelf Life MATERIALS USED Needle (cannula) Outer cap Material: Electro-polished stainless steel (silicone oil coated) Material: Clear Polypropylene (PP) Glue Material: UV glue Lubricant Material: Silicone oil Inner needle cap Material: Clear Polyethylene

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PRODUCT RANGE OVERVIEW Reference code PACKAGING DETAILS Quantity per individual box Quantity per outer box Number of outer boxes per Euro-pallet Length 100 units 50 individual boxes (5000 units total) 30 Height 130 cm 70 cm 70 cm 0.115 kg An individual box contains 100 units 37.5 cm 27.5 cm 37.5 cm 6.3 kg An outer box contains 50 individual boxes (5000 units) Languages 5 languages on IFU, “CAUTION”, and all levels of packaging: English (EN), French (FR), German (DE), Spanish (ES), Italian (IT) Storage conditions Store upright in a clean, dry place. Keep away from sunlight, rain, and moisture....

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Label details Product name Product size Quantity (pieces) Nipro Diabetes Care is part of Nipro Corporation Japan, a leading global healthcare company established in 1954. With over 27,000 employees worldwide, Nipro serves the Medical Device, Pharmaceutical, and Pharmaceutical Packaging industries. Nipro Diabetes Care is a global — supplier of high quality products for people living with type 1 or type 2 diabetes. Our portfolio of meters, test strips, pen needles, and lancets capture the essentials of self-testing in the most simple, accurate, and accessible form. This way we ensure the best life...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.

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