NovaLine Tubing Sets for Hemodialysis

The NovaLine Tubing Sets for Hemodialysis are sterile and single-use only, meaning each set is designed for one patient treatment and must not be reused. They are individually packaged to preserve sterility, so unopened sets should be stored under controlled conditions—typically in a clean, dry environment away from direct sunlight or extreme temperatures. Once opened, the set must be used immediately to avoid contamination risks.

The NovaLine Tubing Sets include tubing with and without anti-regurgitation valves, which prevent backflow of blood between the patient and the dialysis machine. These valves are critical because they maintain the integrity of the extracorporeal circuit during hemodialysis, reducing the risk of air embolism or blood leakage that could compromise patient safety or treatment efficacy.

The NovaLine Tubing Sets are classified as Class II medical devices under FDA product code FJK and comply with both FDA 510(k) clearance (K201866) and MDR (Medical Device Regulation) requirements. This classification means they undergo rigorous pre-market review to ensure safety and performance, and healthcare providers can rely on their compliance with established standards for hemodialysis tubing. The sets are also registered with the FDA under specific registration numbers.

The NovaLine Tubing Sets must be stored in their original, unopened packaging to maintain sterility and functionality. They should be kept in a cool, dry place (typically room temperature) and protected from direct sunlight, moisture, or physical damage. Avoid storing them in areas with extreme temperatures or high humidity, as these conditions could degrade the materials or compromise sterility before use.