Description

The MAXZERO Needle-Free Valve is an innovative medical device designed to enhance the safety and efficiency of intravenous (IV) therapy. This sterile, single-use connector eliminates the need for needles, providing secure access to IV lines and catheters for medication administration. Its primary aim is to reduce the risk of infections, such as central line-associated bloodstream infections (CLABSI), and to prevent catheter occlusions.

Key Features

• Positive-Pressure Valve: The luer-activated valve features a zero reflux mechanism, expelling fluid upon disconnection to prevent blood reflux and reduce occlusions.
• Solid Access Surface: Designed for effective disinfection using 70% isopropyl alcohol, ensuring a clean and secure connection.
• Clear Polycarbonate Housing: Allows easy visualization of the fluid path, enhancing monitoring and management.
• Low Priming Volume: With a priming volume of 0.19 mL, it is suitable for all patient populations, including vulnerable groups such as infants and immunocompromised patients.

Compatibility and Performance

• Broad Compatibility: Works with lipid and harsh infusates and can be disinfected with various agents, including chlorhexidine gluconate and iodine.
• Power Injector Compatible: Supports procedures up to 325 psi at 10 mL/sec with an average flow rate of 8.5 L/hr.
• Change Interval: Recommended to change every 7 days or after 200 activations.

Extension Set Configurations

Available in multiple configurations, including single, bifuse, trifuse, and quadfuse options. It offers various tubing sizes and features such as check valves, filters, and luer lock options to meet diverse clinical needs.

Material and Safety

• Construction Materials: Made from polycarbonate, silicone, and polyethylene, free from DEHP, phthalates, latex, and PVC, with minimal BPA content.
• Sterilization: Electron beam sterilized, ensuring compliance with ISO standards for biocompatibility and safety.

Regulatory Compliance

• Medical Device Classification: Class IIa device with CE marking and compliance with numerous international standards, including ISO 13485 and ISO 14971.
• Packaging and Labeling: Multilingual unit labeling with packaging designed for secure storage and transport.

Manufacturing Details

Manufactured by Sistemas Medicos Alaris SA de C.V. in Mexico, with BD Switzerland Sàrl as the legal manufacturer. The device is designed to improve patient safety by minimizing catheter-related complications, supported by clinical evidence demonstrating reduced occlusion and infection rates.

Shelf Life and Storage

The valve offers a shelf life of 3 years and should be stored at temperatures ranging from -40°C to +52°C, ensuring long-term reliability and performance.