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fresenius 2008t hemodialysis machine
Fresenius Medical Care
Summary: The Fresenius 2008T Hemodialysis Machine is a device used for dialysis treatment in patients with kidney failure. It is primarily used by nephrologists and dialysis nurses in clinical and outpatient settings.
FDA Clearance Information
Pathway
510K
Number
K111639 ↗
Decision Date
October 21, 2011
Product Code
KDI
Device Class
Class 2
Evidence
0 studies
The Fresenius 2008T Hemodialysis Machine was cleared via the FDA 510k pathway on October 21, 2011. Manufactured by Fresenius Medical Care, it is classified as a Class 2 device under product code KDI.
What It Is
The Fresenius 2008T Hemodialysis Machine is a sophisticated medical device designed to perform hemodialysis, a process that filters waste and excess fluids from the blood when the kidneys are no longer able to perform these functions. It operates by circulating the patient's blood through a dialyzer, or artificial kidney, where it is cleansed before being returned to the body. The machine is equipped with advanced monitoring systems to ensure patient safety and treatment efficacy.
Clinical Applications
This device is commonly used in dialysis centers and hospitals to treat patients with chronic kidney disease or acute kidney injury requiring renal replacement therapy. Nephrologists and dialysis nurses oversee its use, ensuring that patients receive the appropriate dialysis dose. It is suitable for adult and pediatric patients, with settings adjustable to accommodate various patient needs and treatment protocols.
Indications for Use
The Fresenius 2008T is indicated for use in patients requiring hemodialysis due to end-stage renal disease or acute kidney injury. It is specifically designed for those who need regular dialysis sessions to manage their kidney function.
Practical Considerations
The machine is compatible with a range of dialyzers and blood tubing sets, allowing for flexibility in treatment. It features user-friendly interfaces and safety alarms to assist clinicians in monitoring treatment. Regular maintenance and calibration are essential to ensure optimal performance.
Related Literature
The linked study explores the use of the Seraph-100 Microbind Affinity Blood Filter in critically ill COVID-19 patients. It reports on four patients who underwent hemoperfusion therapy early in their illness, showing potential benefits in respiratory function. However, the study is limited by its small sample size and lack of a control group, suggesting the need for further research.
Frequently Asked Questions
What is the Fresenius 2008T Hemodialysis Machine used for?
It is used for performing hemodialysis in patients with kidney failure to filter waste and excess fluids from the blood.
What specialties typically use this device?
Nephrologists and dialysis nurses in both hospital and outpatient dialysis center settings.
What are the FDA-cleared indications?
The device is indicated for patients requiring hemodialysis due to 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.