Description

The Unoquip Nelaton Catheter Soft is a specialized medical device designed for effective and safe short-term bladder catheterization. This catheter is primarily intended for use in male patients and is suitable for application in hospitals, clinics, and home care settings by trained medical professionals.

Key Features

• Material: Crafted from soft, flexible, and kink-resistant DEHP-free medical-grade PVC, ensuring comfort and reliability during use. The catheter is latex-free, making it suitable for patients with latex sensitivities.
• Length: Measures 40 cm, tailored for male patients, with other lengths available for pediatric and female use.
• Design: Features a straight, single-lumen tube with an atraumatic, soft, rounded tip for smooth insertion. It includes two gently rounded lateral drainage eyes for efficient urine flow and a closed distal end.
• Connector: Equipped with a funnel-shaped, color-coded connector for easy size identification. Some variants include a blue holding sleeve or sheath to maintain sterility during insertion.

Sterility and Packaging

• Sterilization: Each catheter is EO (ethylene oxide) sterilized and individually packed to ensure sterility.
• Packaging: Available in various configurations, including individual units and boxes of 50, catering to different institutional needs.

Intended Use

The catheter is designed for intermittent bladder catheterization, addressing needs such as urinary retention management, postoperative drainage, sterile urine sample collection, bladder decompression, and intravesical medication administration. It is crucial for diagnostic procedures requiring bladder access.

Usage Guidelines

• Single-Use: Intended for single use only. Re-sterilization is not recommended.
• Aseptic Technique: Proper aseptic technique is advised during insertion to prevent infection.
• Lubrication: Recommended to enhance patient comfort and minimize trauma.
• Storage: Should be stored away from extreme temperatures, humidity, and direct sunlight. Use only if packaging is intact.

Regulatory Compliance

• Classification: Classified as a Class IIa medical device.
• Standards: Manufactured in compliance with ISO 13485:2016 standards and holds a CE Certificate, ensuring adherence to high-quality medical device regulations.

This detailed design and comprehensive feature set make the Unoquip Nelaton Catheter Soft a reliable choice for healthcare professionals seeking effective urinary catheterization solutions.