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2008t bluestar hemodialysis machine
Fresenius Medical Care Renal Therapies Group
Summary: The 2008t bluestar hemodialysis machine is used for dialysis treatment in patients with renal failure. It is primarily used by nephrologists and dialysis technicians in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K173972 ↗
Decision Date
May 10, 2018
Product Code
KDI
Device Class
Class 2
Evidence
0 studies
The 2008t bluestar hemodialysis machine was cleared through the FDA 510k pathway on May 10, 2018. Manufactured by Fresenius Medical Care Renal Therapies Group, it is classified as a Class 2 device.
What It Is
The 2008t bluestar hemodialysis machine is a sophisticated medical device designed to perform hemodialysis, a process that filters waste and excess fluid from the blood when the kidneys are not functioning properly. It operates by circulating the patient's blood through a dialyzer, or artificial kidney, where toxins and fluids are removed. The machine ensures precise control over dialysis parameters, enhancing treatment safety and efficacy.
Clinical Applications
This device is commonly used in dialysis centers and hospitals for patients with chronic kidney disease or acute kidney injury requiring renal replacement therapy. Nephrologists, along with trained dialysis nurses and technicians, operate the machine to provide lifesaving treatment. It is suitable for adult and pediatric patients, with settings adjustable to meet individual patient needs.
Indications for Use
The 2008t bluestar hemodialysis machine is indicated for patients with end-stage renal disease or acute renal failure who require dialysis. It is used to manage fluid and electrolyte balance and remove waste products from the blood.
Practical Considerations
The machine is compatible with various dialyzers and bloodline sets, allowing flexibility in treatment. It is important to ensure proper setup and calibration before use. Regular maintenance and adherence to operating protocols are essential for optimal performance and patient safety.
Frequently Asked Questions
What is 2008t bluestar hemodialysis machine used for?
It is used for hemodialysis treatment in patients with kidney failure to remove waste and excess fluid from the blood.
What specialties typically use this device?
Nephrology and dialysis technicians primarily use this device in clinical settings such as dialysis centers and hospitals.
What are the FDA-cleared indications?
It is indicated for patients with end-stage renal disease or acute renal failure requiring dialysis to manage fluid and electrolyte balance.
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.