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fresenius 2008t hemodialysis machine
Fresenius Medical Care North America
Summary: The Fresenius 2008T Hemodialysis Machine is used for hemodialysis treatment in patients with kidney failure. It is primarily used by nephrologists and dialysis technicians in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K113427 ↗
Decision Date
December 21, 2011
Product Code
KDI
Device Class
Class 2
Evidence
0 studies
The Fresenius 2008T Hemodialysis Machine was cleared through the FDA 510k pathway on December 21, 2011. Manufactured by Fresenius Medical Care North America, it is classified as a Class 2 device.
What It Is
The Fresenius 2008T Hemodialysis Machine is a 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 do so effectively. The machine works by circulating the patient's blood through a dialyzer, where it is cleaned before being returned to the body. This device is critical for managing patients with end-stage renal disease (ESRD) and is equipped with advanced features to ensure patient safety and treatment efficacy.
Clinical Applications
The Fresenius 2008T is commonly used in dialysis centers and hospitals for patients with chronic kidney disease requiring regular dialysis sessions. It is essential in nephrology practices and is used by healthcare professionals trained in dialysis procedures. The machine is suitable for adult and pediatric patients, allowing for customized treatment settings based on individual patient needs.
Indications for Use
The FDA-cleared indications for the Fresenius 2008T include use in patients with kidney failure who require hemodialysis to remove waste products and excess fluid from the blood. It is intended for patients with chronic kidney disease or acute kidney injury.
Practical Considerations
The Fresenius 2008T is compatible with various dialyzers and bloodline sets, allowing for flexibility in treatment protocols. It features user-friendly interfaces and safety alarms to ensure effective and safe dialysis sessions. Regular maintenance and calibration are necessary to maintain optimal performance.
Related Literature
The linked study titled 'Seraph-100 Hemoperfusion in SARS-CoV-2-Infected Patients Early in Critical Illness: A Case Series' explored the use of the Seraph-100 Microbind Affinity Blood Filter in COVID-19 patients. The study involved four critically ill patients who received hemoperfusion therapy early in their illness. Key findings suggested potential benefits in altering the course of respiratory failure, although the small sample size limits generalizability.
Frequently Asked Questions
What is the Fresenius 2008T Hemodialysis Machine used for?
It is used for hemodialysis treatment in patients with kidney failure to remove waste products and excess fluids from the blood.
What specialties typically use this device?
Nephrology specialists and dialysis technicians commonly use this device in clinical settings such as dialysis centers and hospitals.
What are the FDA-cleared indications?
The device is indicated for use in patients with kidney failure who require hemodialysis to manage waste and fluid removal from the blood.
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.