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fresenius model 2008t hemodialysis machine
Fresenius Medical Care North America
Summary: The Fresenius Model 2008T Hemodialysis Machine is a medical device used for dialysis treatment in patients with renal failure. It is primarily used by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway 510K
Number K080964 ↗
Decision Date January 14, 2009
Product Code KDI
Device Class Class 2
Evidence 0 studies
The Fresenius Model 2008T Hemodialysis Machine was cleared through the FDA 510(k) pathway on January 14, 2009. Manufactured by Fresenius Medical Care North America, it is classified as a Class 2 device under product code KDI.
What It Is
The Fresenius Model 2008T Hemodialysis Machine is designed to perform hemodialysis, a process that filters waste and excess fluids from the blood when the kidneys are not functioning properly. The machine works by diverting blood from the patient into a dialyzer, where it is cleaned before being returned to the body. This device is equipped with advanced features to monitor and control the dialysis process, ensuring patient safety and treatment efficacy.
Clinical Applications
This hemodialysis machine is commonly used in hospitals and outpatient dialysis centers. It is primarily utilized by nephrologists and dialysis nurses to treat patients with chronic kidney disease or acute kidney injury requiring renal replacement therapy. The device is suitable for adult and pediatric patients who need regular dialysis sessions to manage their kidney function.
Indications for Use
The FDA indications for the Fresenius Model 2008T Hemodialysis Machine include its use in patients with end-stage renal disease or acute kidney failure. It is intended for individuals who require dialysis to remove waste products and excess fluid from their blood due to impaired kidney function.
Practical Considerations
The Fresenius Model 2008T is compatible with various dialyzer types and sizes, allowing customization based on patient needs. Clinicians should be trained in its operation to ensure optimal performance and patient safety. Regular maintenance and calibration are essential for accurate treatment delivery.
Frequently Asked Questions
What is the Fresenius Model 2008T Hemodialysis Machine used for?
It is used for performing hemodialysis in patients with renal failure to remove waste products and excess fluids from the blood.
What specialties typically use this device?
Nephrology and dialysis nursing specialties primarily use this device in clinical settings such as hospitals and dialysis centers.
What are the FDA-cleared indications?
The device is indicated for use in patients with end-stage renal disease or acute kidney failure who require dialysis to manage kidney function.
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.