đź“‹ FDA Reference
combiset hemodialysis blood tubing set
Fresenius Medical Care Renal Therapies Group
Summary: The Combiset Hemodialysis Blood Tubing Set is used in hemodialysis to connect the patient's blood circulation to the dialysis machine. It is primarily used by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K213992 ↗
Decision Date
May 31, 2023
Product Code
FJK
Device Class
Class 2
Evidence
0 studies
The Combiset Hemodialysis Blood Tubing Set was cleared through the FDA 510(k) pathway on May 31, 2023. Manufactured by Fresenius Medical Care Renal Therapies Group, it is classified as a Class 2 device.
What It Is
The Combiset Hemodialysis Blood Tubing Set is a medical device designed to facilitate the connection between a patient's vascular access and a hemodialysis machine. It consists of tubing and connectors that ensure the safe and efficient transport of blood to and from the dialysis machine. This device is crucial in maintaining the sterility and integrity of the blood circuit during dialysis sessions.
Clinical Applications
This device is commonly used in dialysis centers and hospitals where patients with chronic kidney disease undergo hemodialysis. Nephrologists and dialysis nurses use it to manage patients requiring renal replacement therapy. It is suitable for adult and pediatric patients who need regular dialysis due to kidney failure.
Indications for Use
The device is indicated for use in patients who require hemodialysis, typically those with end-stage renal disease or acute kidney injury. It helps in the extracorporeal removal of waste products and excess fluid from the blood.
Practical Considerations
The tubing set is available in various lengths and configurations to accommodate different dialysis machines and patient needs. It is important to ensure compatibility with the specific dialysis equipment in use. Proper technique in connecting and securing the tubing is essential to prevent leaks and ensure patient safety.
Frequently Asked Questions
What is the Combiset Hemodialysis Blood Tubing Set used for?
It is used to connect a patient's blood circulation to a hemodialysis machine during dialysis treatment.
What specialties typically use this device?
Nephrology and dialysis nursing specialties typically use this device in dialysis centers and hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring hemodialysis, such as those with end-stage renal 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.