Production
and wholesale of medical products

Specifications:

•  The device consists of an injection needle 0,8x38mm (21Gx1 ½), “Luer” connection, a latex connector, a long PVC tube, a plastic clip with a roller (flow regulator), a plastic bottle with a mesh filter and a plastic needle to penetrate into the container.
•  The tip of the injection needle is sharp, without bumps or burrs.
•  The connection between the needle connector and the plastic tube is smooth, without bending.
• The flow rate is set using a roller clamp at the rate of 20 drops = 1 ml.
•  Sterilization: ethylene oxide.
•  The device complies with the requirements of standards EN ISO 8536-4: 2013

Indications for use:

Device PC brand IGAR, intended for the transfusion of blood substitutes and infusion solutions.

Do not apply:

• for transfusion of blood and blood components;
• in case of violation of the integrity of the consumer packaging;
• after the expiration date.

Packing:

Packaging: 1 piece in an individual plastic bag / 25 pieces in a group package / 400 pieces in a transport box.

Application:

The device is intended for infusion of blood substitutes and infusion solutions.

Do not use the medical device in case of damage to the package and / or after contact with a non-sterile surfaces. Disclosed packings, used or unused medical device must be disposed of in accordance to the requirements of national standards.

Shelf life:

Shelf life: 3 years.

Manufacturer: “IGAR Ltd”, Ukraine

Certification:

The medical device is declared and placed on the market of Ukraine according to the requirements of Technical regulations and Conformity Assessment of medical devices, the product has a complete package of documents and packing labelling in Ukrainian language according to the national standards and Technical regulations.

Quality management system of the Manufacturer meets the requirements of DSTU EN ISO 13485.