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renax hemodialysis blood tubing set sunder hemodialysis blood tubing set
Sunder Biomedical Tech.
Summary: The Renax Hemodialysis Blood Tubing Set is used in hemodialysis procedures to connect patients to dialysis machines. It is primarily used by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K014140 ↗
Decision Date
November 18, 2002
Product Code
FJK
Device Class
Class 2
Evidence
0 studies
The Renax Hemodialysis Blood Tubing Set, manufactured by Sunder Biomedical Tech., received FDA clearance through the 510(k) pathway on November 18, 2002. It is classified as a Class 2 medical device.
What It Is
The Renax Hemodialysis Blood Tubing Set is a medical device used in hemodialysis to facilitate the transfer of blood between the patient and the dialysis machine. It comprises tubing and connectors that are designed to be compatible with standard dialysis equipment. The device ensures safe and efficient blood flow, which is critical for effective dialysis treatment.
Clinical Applications
This device is commonly used in dialysis centers and hospitals during hemodialysis sessions. It is essential for patients with chronic kidney disease who require regular dialysis to manage their condition. Nephrologists and dialysis nurses use this tubing set to ensure a sterile and efficient connection between the patient and the dialysis machine.
Indications for Use
The Renax Hemodialysis Blood Tubing Set is indicated for use in patients undergoing hemodialysis. It is suitable for individuals with end-stage renal disease or acute kidney injury who need dialysis to filter waste from their blood.
Practical Considerations
The tubing set typically comes in various lengths and configurations to accommodate different dialysis machines and patient needs. It is important to ensure compatibility with the dialysis machine being used. Proper technique in connecting and securing the tubing is crucial to prevent leaks or disconnections during treatment.
Frequently Asked Questions
What is the Renax Hemodialysis Blood Tubing Set used for?
It is used to connect patients to dialysis machines during hemodialysis, allowing for the transfer of blood for filtration.
What specialties typically use this device?
Nephrologists and dialysis nurses primarily use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
The device is indicated for use in patients undergoing hemodialysis, particularly those with chronic kidney disease or acute kidney injury.
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.