Description

Manufactured by ICU Medical Inc., the APPX 1.2 ML BIFUSE EXT SET is a specialized medical device designed to enhance the safety and efficiency of intravenous (IV) therapy. This sterile extension set is intended for use with vascular access devices, providing a reliable solution for direct injection, continuous or intermittent infusion, aspiration, and needle-free delivery of medications and solutions.

Key Features

• Bifuse Design: The set features a bifuse (two-branch) configuration, allowing for versatile management of IV lines.
• Needle-Free Connectors: Equipped with two needle-free connectors, such as SmartSite™, BD MaxPlus™, or BD MaxZero™, depending on the model, to minimize the risk of needlestick injuries and enhance patient safety.
• Slide Clamps: Includes two slide clamps for secure line management.
• Luer Lock Connector: Comes with a male luer lock connector, either spin or fixed, based on the model.
• Tubing Options: Available in standardbore, smallbore, or minibore tubing, with lengths typically ranging from 10 to 25.4 cm.

Material and Safety Specifications

• Latex-Free: Not made with natural rubber latex, reducing the risk of allergic reactions.
• Material Composition: Some models are free from DEHP and PVC, and offer lipid resistance.
• Pressure Rating: Certain models are pressure rated, with specifications up to 400 psig.
• Sterile Fluid Path: Ensures a non-contaminated delivery of fluids.

Usage Instructions

• Single-Use Only: The device is non-pyrogenic and intended for single patient use. It should not be resterilized or reused.
• Packaging Integrity: Use only if the package is unopened and undamaged.
• Disinfection Protocol: All needle-free ports must be disinfected before use, and open ports should not be left exposed.
• Replacement Guidelines: The device should be changed according to recognized IV therapy guidelines.

Regulatory and Manufacturing Details

• Health Canada Registration: Some models are registered with Health Canada.
• Manufactured in Mexico: Ensuring adherence to high-quality manufacturing standards.
• Packaging: Typically packaged in cases of 50 or 100 units, model-dependent.
• Sales Restriction: Restricted to sale by or on the order of a physician, aligning with professional healthcare standards.

This IV extension set is a crucial component for healthcare providers, offering reliable performance and compatibility with existing IV systems. Its thoughtful design and robust safety features make it an essential tool in clinical settings.