Diafine lancing needle 32g x 4mm - 100 needles for insulin pens

Product Description

Diafine Lancing Needle is a sterile, single-use medical device designed for the subcutaneous injection of insulin via an injector pen.

Indications

Sterile, double-ended, single-use medical device designed for use with a needle injection system (e.g., an injector pen) that meets the specifications of EN ISO 11608-1 for the subcutaneous injection of insulin. Insulin pen needles are used by consumers, caregivers, and healthcare professionals under the instructions of doctors. It consists of a double-ended needle tube, connected to the needle hub with a connector, a needle container, a needle shield, and sealing paper.

The shield, container, and hub, together with the sealing paper, provide physical protection to the needle. The hub can be screwed onto a needle injection system (e.g., an injector pen) for subcutaneous insulin injection. The product is primarily individually packaged and sterilized to a Sal of 10-6 by gamma sterilization. It is Disposable use only.

The hub has standard internal threads (means of securing the needle assembly), allowing it to be screwed onto the pen injector device. The patient and the end of the product cartridge are lubricated using a medical silicone-based lubricant to facilitate injection (to reduce pain) and penetration of the rubber septum.

A shield is mounted on the end of the needle to protect the tip from accidental damage. Each needle is protected by a peel-off seal to provide a barrier against sterility. To use a pen needle, the user must remove the seal, attach it to the pen injector, and remove the needle container accordingly. Afterwards, the user must remove the inner needle shield to expose the needle and perform an injection. After the injection, the user must insert the used pen needle into the needle holder to remove the pen needle from the injector and dispose of it properly.

Directions for Use and Dosage

• Remove the seal.
• Align the needle with the pen injector.
• Firmly screw the needle onto the pen injector. Keep the needle straight and free from damage.
• Remove the needle holder along the pen injector.
• Remove the needle shield to expose the needle.
• Perform an injection as directed by your doctor. Be sure to perform the injection safety test according to the injector's instructions for use.
• Insert the used pen needle into the needle container.
• Remove the pen needle from the pen injector and dispose of it properly.

Warnings

Before use, check the packaging for damage. Single use only; do not reuse the product. Use within the shelf life. Use with an ISO-compliant pen injector and use with doctor's advice and refer to the IFU for pen injectors. Keep the product and any components out of reach of children.

Storage

Store in a dry, well-ventilated place. The products should not be mixed with virulent, harmful, or corrosive materials.

Size

100 needles