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2008t bluestar hemodialysis machine
Fresenius Medical Care Renal Therapies Group
Summary: The 2008t Bluestar Hemodialysis Machine is used for hemodialysis treatment in patients with renal failure. It is primarily used by nephrologists and dialysis technicians in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K231125 ↗
Decision Date
December 6, 2023
Product Code
KDI
Device Class
Class 2
Evidence
0 studies
The 2008t Bluestar Hemodialysis Machine, manufactured by Fresenius Medical Care Renal Therapies Group, was cleared via the FDA 510k pathway on December 6, 2023. It is classified as a Class 2 device.
What It Is
The 2008t Bluestar Hemodialysis Machine is a medical device designed to perform hemodialysis, a process that filters waste products and excess fluid from the blood when the kidneys are not functioning properly. This machine regulates the flow of blood and dialysate, ensuring efficient removal of toxins. It is equipped with advanced monitoring systems to enhance patient safety and treatment efficacy.
Clinical Applications
This device is commonly used in outpatient dialysis centers and hospital settings for patients with chronic kidney disease or acute renal failure requiring dialysis. Nephrologists and dialysis nurses use it to provide life-sustaining treatment to patients who have lost kidney function. It is suitable for adult and pediatric populations, with settings adjustable for individual patient needs.
Indications for Use
The 2008t Bluestar Hemodialysis Machine is indicated for patients who require hemodialysis due to kidney failure. It is used to manage conditions such as end-stage renal disease (ESRD) and acute kidney injury (AKI).
Practical Considerations
The machine is compatible with standard dialysis access devices and can accommodate various dialyzer sizes. It requires trained personnel for operation, and regular maintenance is essential to ensure optimal performance and patient safety.
Frequently Asked Questions
What is the 2008t Bluestar 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?
Nephrology and dialysis centers primarily use this device, with nephrologists and dialysis technicians operating it.
What are the FDA-cleared indications?
It is indicated for patients requiring hemodialysis due to conditions like end-stage renal disease and 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.