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fresenius 2008t hemodialysis machine
Fresenius Medical Care North America, Design Cente
Summary: The Fresenius 2008T Hemodialysis Machine is a medical device used for hemodialysis in patients with renal failure. It is primarily used by nephrologists and dialysis technicians in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K120505 ↗
Decision Date
March 6, 2012
Product Code
KDI
Device Class
Class 2
Evidence
0 studies
The Fresenius 2008T Hemodialysis Machine was cleared through the FDA 510(k) pathway on March 6, 2012. It is manufactured by Fresenius Medical Care North America and is classified as a Class 2 device.
What It Is
The Fresenius 2008T Hemodialysis Machine is a sophisticated device designed to perform hemodialysis, a process that filters waste products and excess fluids from the blood when the kidneys are not functioning properly. It operates by circulating the patient’s blood through a dialyzer, where it is cleaned and then returned to the body. This machine is equipped with advanced features to ensure patient safety and treatment efficacy, including real-time monitoring of treatment parameters.
Clinical Applications
This machine is commonly used in dialysis centers and hospitals for patients with chronic kidney disease or acute kidney injury requiring renal replacement therapy. It is utilized by nephrologists and dialysis nurses to manage patients who need regular dialysis sessions. The device is suitable for adult and pediatric patients, with settings adjustable to accommodate different patient sizes and treatment needs.
Indications for Use
The Fresenius 2008T Hemodialysis Machine is indicated for use in patients with end-stage renal disease or acute kidney failure who require hemodialysis to remove waste products from their blood. It is suitable for patients who have lost kidney function and need regular dialysis treatments to maintain their health.
Practical Considerations
The Fresenius 2008T is compatible with a range of dialyzers and bloodlines, allowing flexibility in treatment protocols. It is important for clinicians to be familiar with the machine’s interface and safety features to ensure effective and safe dialysis sessions. Regular maintenance and calibration are essential for optimal performance.
Related Literature
The linked study investigated the use of the Seraph-100 Hemoperfusion device in critically ill COVID-19 patients. Four patients with severe respiratory failure were treated with the Seraph-100, which is used in conjunction with a conventional dialysis machine like the Fresenius 2008T. The study reported improvements in respiratory parameters, but the small sample size and lack of a control group limit the generalizability of the findings.
Frequently Asked Questions
What is the Fresenius 2008T Hemodialysis Machine used for?
It is used for performing hemodialysis in patients with kidney failure to remove waste products and excess fluid from the blood.
What specialties typically use this device?
Nephrologists and dialysis technicians commonly use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
It is indicated for patients with end-stage renal disease or acute kidney failure who require hemodialysis.
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.