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fresenius hemodialysis machine a1008 bsm
Seratronics
Summary: The Fresenius Hemodialysis Machine A1008 BSM by Seratronics is a medical device used for hemodialysis in patients with renal failure. It is typically used by nephrologists and dialysis technicians in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K855001 ↗
Decision Date
January 21, 1986
Product Code
FLC
Device Class
Class 2
Evidence
0 studies
The Fresenius Hemodialysis Machine A1008 BSM received FDA clearance through the 510(k) pathway on January 21, 1986. Manufactured by Seratronics, it is classified as a Class 2 medical device.
What It Is
The Fresenius Hemodialysis Machine A1008 BSM is a device designed to perform hemodialysis, a process that removes waste products and excess fluid from the blood when the kidneys are not functioning properly. It works by circulating the patient's blood through a dialyzer, where it is filtered and then returned to the body. This machine is essential for managing chronic kidney disease and acute kidney injury.
Clinical Applications
This hemodialysis machine is commonly used in dialysis centers and hospitals for patients with end-stage renal disease or acute kidney injury requiring renal replacement therapy. Nephrologists and dialysis nurses typically operate the machine, ensuring proper setup and monitoring during treatment. It is suitable for adult and pediatric patients who require regular dialysis sessions.
Indications for Use
The device is indicated for patients with renal failure who need hemodialysis to manage their condition. It is suitable for individuals with chronic kidney disease or acute kidney injury, helping to maintain electrolyte balance and remove toxins from the blood.
Practical Considerations
The Fresenius Hemodialysis Machine A1008 BSM is compatible with standard dialysis setups and requires connection to a water treatment system. Clinicians should ensure proper training in machine operation and patient monitoring during dialysis sessions. Regular maintenance and calibration are essential for optimal performance.
Frequently Asked Questions
What is the Fresenius Hemodialysis Machine A1008 BSM used for?
It is used for performing hemodialysis in patients with renal failure to remove waste products and excess fluid from the blood.
What specialties typically use this device?
Nephrology and dialysis technicians typically use this device in dialysis centers and hospital settings.
What are the FDA-cleared indications?
The device is indicated for patients with renal failure requiring hemodialysis, such as those with chronic kidney 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.