📋 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 ?
510(k)
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.
FDA-Cleared Indications
- Use as blood tubing for hemodialysis procedures.
- Connect a patient's vascular access to compatible hemodialysis equipment.
- Provide the extracorporeal pathway for blood during dialysis treatment.
Clinical Applications
- Routine hemodialysis in patients with kidney failure.
- Hemodialysis for patients receiving renal replacement therapy in a dialysis center or hospital.
- Connection of an arteriovenous fistula, arteriovenous graft, or dialysis catheter to compatible hemodialysis equipment.
- Transport of blood between the patient and the dialyzer during a hemodialysis session.
Practical Considerations
- Confirm that the tubing set's connectors, configuration, and length are compatible with the specific hemodialysis machine and dialyzer.
- Use sterile technique and follow the manufacturer's instructions for priming, connecting, securing, and monitoring the circuit.
- Inspect the tubing and connectors for damage, leaks, kinks, or air before and during treatment.
- This is an extracorporeal blood circuit, not an implantable device; it is generally intended for single-session use and should not be reused unless the labeling specifically permits it.
- MRI safety depends on the complete dialysis setup and any attached components; do not bring an active extracorporeal circuit or connected dialysis machine into the MRI environment without confirming compatibility.
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.