đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- For use during hemodialysis procedures to establish the blood pathway between the patient and the dialysis machine.
Clinical Applications
- Connecting a patient’s vascular access to the extracorporeal blood circuit during hemodialysis.
- Carrying blood from the patient to the dialysis machine and returning treated blood to the patient.
- Use with compatible hemodialysis equipment in hospitals and outpatient dialysis centers.
- Use during hemodialysis for patients receiving renal replacement therapy.
Practical Considerations
- Confirm that the tubing set’s connectors, configuration and dimensions are compatible with the dialysis machine and dialyzer.
- Use sterile technique and inspect the tubing, clamps, connectors and packaging before treatment.
- Secure all connections and monitor for leaks, disconnection, air entry, clotting and abnormal pressures during dialysis.
- This is an extracorporeal blood circuit component; it is not implanted and is not independently evaluated as an MRI device.
- Follow the manufacturer’s labeling and facility protocol for single-use handling, priming, storage and disposal.
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.