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fresenius arterial bloodline sets for hemodialysis fresenius combi sets hemodialysis blood tubing sets
Fresenius Medical Care North America
Summary: The Fresenius arterial bloodline sets are used in hemodialysis to facilitate blood flow between the patient and the dialysis machine. They are primarily used by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K012242 ↗
Decision Date
August 16, 2001
Product Code
FJK
Device Class
Class 2
Evidence
0 studies
The Fresenius arterial bloodline sets were cleared via the FDA 510k pathway on August 16, 2001. Manufactured by Fresenius Medical Care North America, this Class 2 device is categorized under product code FJK.
What It Is
The Fresenius arterial bloodline sets are components used in hemodialysis, a procedure to filter waste and excess fluids from the blood when the kidneys are not functioning properly. These sets include tubing and connectors that create a circuit for blood to flow from the patient to the dialysis machine and back, ensuring efficient dialysis treatment. They are designed to be compatible with Fresenius dialysis machines and are critical for maintaining a sterile and effective dialysis process.
Clinical Applications
These bloodline sets are commonly used in dialysis centers and hospital settings where patients with chronic kidney disease or acute kidney injury require hemodialysis. Nephrologists and dialysis nurses use these sets to establish and maintain vascular access during dialysis sessions. They are essential in managing patients with end-stage renal disease, ensuring safe and effective treatment.
Indications for Use
The FDA indications for these bloodline sets include use in hemodialysis procedures for patients requiring renal replacement therapy. They are suitable for patients with chronic kidney disease who need regular dialysis to manage their condition.
Practical Considerations
These bloodline sets are available in various configurations to accommodate different patient sizes and dialysis machine models. Compatibility with Fresenius dialysis machines is a key consideration, and proper technique in connecting and priming the lines is essential to prevent air embolism and ensure patient safety.
Frequently Asked Questions
What is the Fresenius arterial bloodline set used for?
It is used in hemodialysis to facilitate blood flow between the patient and the dialysis machine.
What specialties typically use this device?
Nephrologists and dialysis nurses typically use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
The device is indicated for use in hemodialysis procedures for patients requiring renal replacement therapy.
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.