Description

The CLEARLINK Syringe Adaptor Set is an essential component of the CLEARLINK System, crafted by Baxter Healthcare to enhance the safety and efficiency of intravenous (IV) therapy. This single-use, disposable medical device is designed for healthcare professionals, providing seamless administration and withdrawal of fluids, including medications, through vascular access devices.

Key Features

• Needleless Access: Equipped with the CLEARLINK Luer Activated Valve, this adaptor set offers needleless access, minimizing the risk of needlestick injuries and enhancing safety.
• Secure Connections: Compatible with standard male Luer adapters, such as syringes and IV sets, it ensures secure connections to prevent accidental disconnections and reduce the risk of air embolisms.
• Y-Site Port: Includes a Y-Site port for secondary medication administration, providing flexibility in fluid management.

Design and Safety

• Clear Visualization: The clear body design allows for easy visualization of blood, ensuring accurate monitoring.
• Flat Septum: Features a flat septum for ease of cleaning and a double seal to prevent microbial ingress, maintaining sterility.
• Material Composition: Constructed from non-DEHP and non-PVC materials, enhancing biocompatibility and patient safety.

Performance and Testing

• Microbial Barrier: Underwent rigorous microbial barrier challenge testing to ensure protection against infections.
• Nonclinical Bench Tests: Includes tests for pressure differential, lipid resistance, and ultrasonic weld joint performance, confirming reliability and durability.

Packaging and Configuration

Available individually or in cartons of 200 units, the CLEARLINK Syringe Adaptor Set may include various configurations such as Luer lock adapters, retractable collars, and stopcock manifold extension sets. These features make it a versatile tool in maintaining aseptic conditions in diverse healthcare settings.

Regulatory Information

Classified as an IV Administration Set under regulatory code 21 CFR 880.5440, this Class II device aligns with previously cleared devices, incorporating minor design enhancements for optimized manufacturing. Its robust design and comprehensive testing make it a trusted choice for healthcare providers seeking effective fluid management solutions.