Description

The DRAIN MALECOT BARDEX is a specialized catheter designed for effective drainage in nephrostomy and other urological procedures. Its unique Malecot wing design ensures secure placement and enhanced drainage, making it suitable for both renal and bladder applications. Available in a variety of French sizes, this catheter offers versatility to meet diverse clinical needs.

Key Features

• Malecot Wing Design: The 4-wing tip provides reliable retention and effective drainage.
• Material Options: Constructed from natural rubber latex, with polyurethane and silicone variants for those with latex sensitivity.
• Size Variability: Available in sizes ranging from 8Fr to 36Fr, with lengths typically 14 inches for latex models and 20–25 cm for silicone models.
• Hydrophilic Coating: Some models include this feature for easier insertion.

Design Specifications

• Single-Lumen Tube: Equipped with distal holes or tips for efficient fluid management.
• Proximal Connector: Compatible with urine collection devices, with some models featuring a flexible stylet and urine bag connector.
• Configuration Options: Available in straight or angled designs to accommodate different procedural requirements.

Sterility and Packaging

• Sterile Supply: Each catheter is individually packaged and sterilized, with ethylene oxide used for polyurethane models.
• Packaging Quantity: Typically packaged with six catheters per box or case.
• Single Use: Intended for one-time use to maintain sterility and prevent cross-contamination.

Storage and Shelf Life

• Shelf Life: Up to 3 years for polyurethane models.
• Storage Conditions: Should be stored in a dark, dry, cool place and used immediately after opening.

Precautions

• Latex Warning: Contains natural rubber latex, which may cause allergic reactions.
• Lubricant Compatibility: Should not be used with petroleum-based ointments or lubricants.
• Indwelling Duration: Not recommended to remain indwelling for more than 3 months for PU models or 4 weeks for silicone models.

Regulatory Information

• Medical Device Classification: Class 2, with regulation number 876.5090.
• Prescription Requirement: Intended for use by trained physicians only, ensuring proper handling and application.

The DRAIN MALECOT BARDEX catheter is a reliable choice for healthcare professionals, offering secure drainage solutions tailored to specific patient needs. Its comprehensive design and material options provide flexibility and safety in various clinical settings.