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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
510K
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.
Clinical Applications
These tubing sets are commonly used in hemodialysis centers and hospital dialysis units. They are essential for patients with chronic kidney disease requiring regular dialysis sessions. Nephrologists and dialysis nurses use these devices to manage and maintain the dialysis process, ensuring efficient removal of waste products from the blood.
Indications for Use
The FDA-cleared indications for Novaline Tubing Sets include use in patients requiring hemodialysis due to renal failure. This device is intended for patients who need regular dialysis to manage kidney function.
Practical Considerations
Novaline Tubing Sets come in various lengths and configurations to accommodate different patient sizes and dialysis machine models. Compatibility with standard dialysis machines is a key feature, and clinicians should ensure proper connection and secure fitting to prevent leaks or disconnections during treatment.
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.