Description

The LoFric Classic catheter is a specialized medical device designed for effective and comfortable intermittent urethral catheterization. Its hydrophilic coating, activated with just clean water, ensures a smooth and low-friction experience, enhancing user comfort during insertion and withdrawal. This feature eliminates the need for additional gels, making it ready for use within 30 seconds.

Key Features

• Single-Use and Sterile: Each catheter is individually packaged, ensuring sterility and safety for every use. It is intended for single use, making it suitable for both short- and long-term bladder management.
• Versatile Design: Available in various sizes, lengths, and tip types, including Nelaton and Tiemann, to meet diverse user needs. The catheter is suitable for men, women, and children, and can be used in different settings such as home, hospital, or while traveling.
• Convenient Adhesive Tab: An adhesive tab on the packaging allows for easy placement on dry surfaces, providing practical handling during use.

Material and Safety

Constructed from a polyolefin-based elastomer, the LoFric Classic is free from latex, PVC, and phthalates, ensuring it is non-toxic and biocompatible. It adheres to high safety standards, with no materials derived from human or animal origins. The catheter is compliant with various international standards, including ISO 10993, ensuring its compatibility with the human body.

Environmental Considerations

The product is manufactured without ozone-depleting agents and uses recyclable materials in its packaging. Users are advised to incinerate the catheter and item packaging after use, while recycling the cartons and transport boxes.

Instructions for Use

To activate the catheter, simply add clean water to the pouch and wait for 30 seconds. The adhesive tab can be used to secure the pouch to a dry surface if necessary. Proper hygiene and insertion techniques should be followed as per the instructions provided, and the catheter should be disposed of responsibly after use.

Storage and Shelf Life

The LoFric Classic should be stored in a dry place at room temperature. It boasts a shelf life of 3.5 years, except for the CH06 size, which has a 2-year shelf life. Sterilized using ethylene oxide gas, the catheter should not be resterilized.

Certifications

This Class I sterile medical device complies with numerous standards, including MDD 93/42/EEC, ISO 11607, and ISO 13485. The manufacturing facility is certified to ISO 9001 and ISO 13485, ensuring high-quality production processes.

The LoFric Classic catheter provides a reliable and user-friendly solution for those requiring intermittent catheterization, prioritizing comfort, safety, and environmental responsibility.