đź“‹ FDA Reference
combiset smartech hemodialysis blood tubing set with attached priming set and integrated crit-line technology combiset smartech hemodialysis blood tubing set with attached priming set and intergrated crit-line technology no heparin line
Fresenius Medical Care Renal Therapies Group
Summary: The Combiset Smartech Hemodialysis Blood Tubing Set is used in hemodialysis procedures to facilitate blood circulation between the patient and the dialysis machine. It is primarily used by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K201207 ↗
Decision Date
September 18, 2020
Product Code
KOC
Device Class
Class 2
Evidence
0 studies
The Combiset Smartech Hemodialysis Blood Tubing Set, manufactured by Fresenius Medical Care Renal Therapies Group, was cleared via the FDA 510(k) pathway on September 18, 2020. It is a Class 2 device under product code KOC.
What It Is
This device is a hemodialysis blood tubing set with an integrated priming set and Crit-Line technology, designed to optimize dialysis treatment by monitoring hematocrit levels in real-time. It connects the patient to the dialysis machine, allowing for efficient blood filtration and fluid removal. The absence of a heparin line suggests it is suitable for patients who require anticoagulation management through other means.
Clinical Applications
The Combiset Smartech is commonly used in outpatient dialysis centers and hospital dialysis units. It is essential for patients with chronic kidney disease requiring regular hemodialysis. Nephrologists and dialysis nurses utilize this device to ensure safe and effective dialysis sessions, particularly in adult and elderly populations with end-stage renal disease.
Indications for Use
This device is indicated for use in hemodialysis procedures to assist in the extracorporeal circulation of blood. It is suitable for patients undergoing dialysis who need continuous monitoring of hematocrit and oxygen saturation levels.
Practical Considerations
The tubing set is typically compatible with standard dialysis machines and is available in various lengths to accommodate different patient sizes. Clinicians should ensure proper connection and priming to prevent air embolism and maintain accurate monitoring of hematocrit levels.
Frequently Asked Questions
What is the Combiset Smartech Hemodialysis Blood Tubing Set used for?
It is used to connect patients to dialysis machines, facilitating blood filtration and fluid removal during hemodialysis.
What specialties typically use this device?
Nephrology and dialysis nursing specialties primarily use this device in dialysis centers and hospital settings.
What are the FDA-cleared indications?
It is indicated for use in hemodialysis procedures to manage blood circulation and monitor hematocrit and oxygen saturation levels.
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.