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meridian hemodialysis machine model 5m5576
Baxter Healthcare
Summary: The Meridian Hemodialysis Machine Model 5m5576 is a medical device used for hemodialysis, primarily in patients with kidney failure. It is typically operated by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K053539 ↗
Decision Date
May 24, 2006
Product Code
KDI
Device Class
Class 2
Evidence
0 studies
The Meridian Hemodialysis Machine Model 5m5576 by Baxter Healthcare was cleared through the FDA 510k pathway on May 24, 2006. It is classified as a Class 2 device under product code KDI.
What It Is
The Meridian Hemodialysis Machine Model 5m5576 is a sophisticated 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 do so. It works by circulating the patient's blood through a dialyzer, where it is cleansed before being returned to the body. This machine is equipped with various safety and monitoring features to ensure effective and safe dialysis sessions.
Clinical Applications
This device is commonly used in hospital dialysis units, outpatient dialysis centers, and sometimes in home settings for patients with chronic kidney disease requiring regular dialysis. Nephrologists, dialysis nurses, and technicians typically operate the machine. It is essential for managing patients with end-stage renal disease (ESRD) and acute kidney injury (AKI) who require renal replacement therapy.
Indications for Use
The Meridian Hemodialysis Machine is indicated for patients who need hemodialysis due to kidney failure. It is suitable for those with chronic kidney disease or acute kidney injury where the kidneys cannot adequately filter the blood.
Practical Considerations
The machine is compatible with standard hemodialysis setups and requires connection to a water treatment system. It is important to ensure proper calibration and maintenance to optimize performance. Clinicians should be trained in its operation and troubleshooting to ensure patient safety.
Frequently Asked Questions
What is the Meridian Hemodialysis Machine Model 5m5576 used for?
It is used for performing hemodialysis in patients with kidney failure to remove waste products 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?
It is indicated for patients requiring hemodialysis due to 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.