đź“‹ FDA Reference
Novaline Tubing Sets for Hemodialysis
Bain Medical Equipment (Guangzhou)
Summary: Novaline Tubing Sets are used in hemodialysis to facilitate blood flow between the patient and the dialysis machine. They are primarily used by nephrologists and dialysis nurses in both inpatient and outpatient settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K201866 ↗
Decision Date ?
March 10, 2021
Product Code ?
FJK
Device Class ?
Class 2
Evidence ?
0 studies
The Novaline Tubing Sets were cleared through the FDA 510k pathway on March 10, 2021. Manufactured by Bain Medical Equipment (Guangzhou), this device is classified as Class 2 under product code FJK.
What It Is
Novaline Tubing Sets are medical devices designed for use in hemodialysis procedures. They consist of tubing that connects the patient's vascular access to the dialysis machine, allowing for the exchange of blood and dialysis fluid. The tubing is engineered to ensure biocompatibility and minimize clotting, which is critical for effective dialysis treatment.
FDA-Cleared Indications
- For use during hemodialysis treatment in patients with renal failure.
- For extracorporeal blood circulation between the patient's vascular access and a hemodialysis machine.
Clinical Applications
- Connecting a hemodialysis machine to a patient’s arteriovenous fistula, arteriovenous graft, or dialysis catheter.
- Providing the arterial and venous blood pathways during intermittent hemodialysis.
- Supporting blood circulation through the dialyzer and return of treated blood to the patient.
- Use in hospital dialysis units and outpatient hemodialysis centers when paired with compatible dialysis equipment.
Practical Considerations
- Confirm that the tubing set is compatible with the specific hemodialysis machine, dialyzer, connectors, and prescribed treatment configuration.
- Select the appropriate tubing length and configuration for the patient, access type, machine setup, and clinical workflow.
- Inspect packaging and tubing before use; do not use the set if it is damaged, contaminated, expired, or leaking.
- Prime and connect the set according to the manufacturer’s instructions and dialysis-unit protocol to reduce air entry, blood loss, leaks, and clotting.
- These tubing sets are not implants and are not independently considered MRI devices; MRI use should follow the labeling for the complete dialysis system and any metal components.
Frequently Asked Questions
What is Novaline Tubing Sets used for?
Novaline Tubing Sets are used to connect a patient's vascular access to a dialysis machine during hemodialysis.
What specialties typically use this device?
Nephrologists and dialysis nurses typically use this device in dialysis centers and hospital units.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring hemodialysis due to renal failure.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.