Description

The INSUPEN PEN NEEDLE is a highly specialized medical device crafted for precise and comfortable subcutaneous drug administration. Designed for single use, this sterile needle is ideal for patients ranging from newborns to the elderly, making it suitable for both home and professional healthcare settings.

Key Features

• Precision Engineering: Each needle is meticulously engineered to minimize discomfort and enhance drug delivery efficiency. The advanced design includes a wide internal diameter, known as Super Thin Wall technology, to improve medication flow and reduce injection time.

• Advanced Sharpening Techniques: Utilizing Soft Sharpening technology and Extr3me geometry, the needle features a sharper bevel with reduced friction, resulting in gentler and less painful injections.

• Medical-Grade Silicone Lubrication: Both ends of the double-ended cannula are lubricated to ensure smooth penetration and minimize discomfort.

Compatibility and Safety

• Universal Compatibility: The needle's double-ended cannula is securely attached to an injection-molded hub, ensuring compatibility with all major insulin pens and pen injector devices, including models from ClikStar, KwikPen, Novopen, and many others.

• Safety Features: Equipped with a safe remover to mitigate the risk of accidental needlestick injuries. However, it is marked as MR Unsafe, indicating it should not be used in MRI environments.

Size Variations

Available in a range of gauges from 29G to 34G and lengths from 3.5 mm to 12 mm, the INSUPEN PEN NEEDLE offers notable options such as the exceptionally thin 33G/4mm model. This variety allows for tailored selection based on individual patient needs.

Material and Manufacturing

• High-Quality Materials: Constructed from medical-grade stainless steel, with components made from polypropylene and polyethylene. The needle is bonded with UV glue and sterilized using ethylene oxide to ensure the highest standards of hygiene.

Compliance and Standards

The device complies with several international standards, including ISO 11608-2, ISO 9626, and ISO 10993-1, and holds a CE Mark. It is classified as a Class II medical device under 21 CFR 880.5570, ensuring adherence to rigorous safety and quality benchmarks.

Packaging and Shelf Life

Each box contains 100 needles, with 12 boxes per carton. The packaging includes a primary polyethylene container sealed with medical-grade paper. The product boasts a shelf life of five years, contingent on maintaining packaging integrity and appropriate storage conditions.

Best Practices

For optimal use, select the appropriate needle length and gauge, inject at a 90° angle (or 45° for children and very thin patients), and dispose of the needle after a single use in a puncture-proof container. This ensures safety and effectiveness in managing subcutaneous injections for insulin and other medications.