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fresenius 2008t hemodialysis machine model 190573
Fresenius Medical Care North America, Design Cente
Summary: The Fresenius 2008T Hemodialysis Machine is used for renal replacement therapy in patients with end-stage renal disease. It is primarily operated by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K101715 ↗
Decision Date
December 21, 2010
Product Code
KDI
Device Class
Class 2
Evidence
0 studies
The Fresenius 2008T Hemodialysis Machine was cleared through the FDA 510(k) pathway on December 21, 2010. It is manufactured by Fresenius Medical Care North America and is classified as a Class 2 device under product code KDI.
What It Is
The Fresenius 2008T Hemodialysis Machine is a medical device designed to perform hemodialysis, a process that filters waste products and excess fluids from the blood when the kidneys are no longer able to function effectively. The machine uses a dialyzer, often referred to as an artificial kidney, to clean the blood. It is equipped with advanced features for monitoring and adjusting treatment parameters to ensure patient safety and treatment efficacy.
Clinical Applications
This device is commonly used in hospital dialysis units, outpatient dialysis centers, and sometimes in home settings for patients with end-stage renal disease. Nephrologists and dialysis nurses use it to manage chronic kidney disease patients who require regular dialysis sessions. It is essential for maintaining electrolyte balance and removing toxins in patients who have lost kidney function.
Indications for Use
The FDA-cleared indications for the Fresenius 2008T Hemodialysis Machine include its use in patients with end-stage renal disease who require hemodialysis. It is suitable for adult and pediatric patients who need renal replacement therapy.
Practical Considerations
The machine is compatible with various dialyzers and bloodline sets, allowing for flexibility in treatment. It requires regular maintenance and calibration to ensure accurate performance. Clinicians should be trained in its operation and troubleshooting to manage any technical issues that may arise during treatment.
Frequently Asked Questions
What is the Fresenius 2008T Hemodialysis Machine used for?
It is used for performing hemodialysis in patients with end-stage renal disease to filter waste and excess fluids from the blood.
What specialties typically use this device?
Nephrologists and dialysis nurses typically use this device in dialysis centers and hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in patients with end-stage renal disease 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.