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meridian hemodialysis machine model 5m5576
Baxter Healthcare
Summary: The Meridian Hemodialysis Machine Model 5m5576 is a device used for hemodialysis, primarily by nephrologists and dialysis specialists, to treat patients with renal failure.
FDA Clearance Information
Pathway
510K
Number
K992894 ↗
Decision Date
November 24, 1999
Product Code
KDI
Device Class
Class 2
Evidence
0 studies
The Meridian Hemodialysis Machine Model 5m5576 by Baxter Healthcare was cleared through the FDA 510(k) pathway on November 24, 1999. It is a Class 2 medical device.
What It Is
The Meridian Hemodialysis Machine Model 5m5576 is a medical device designed for hemodialysis, a process that filters and purifies the blood using a machine. This is essential for patients whose kidneys are not functioning properly. The device works by removing waste products and excess fluid from the blood, which is crucial for maintaining the body's chemical balance.
Clinical Applications
This device is commonly used in dialysis centers and hospitals by nephrologists and dialysis nurses. It is primarily used for patients with chronic kidney disease or acute kidney injury who require regular dialysis sessions. The machine is suitable for adult and pediatric patients, depending on the specific clinical needs and dialysis prescriptions.
Indications for Use
The Meridian Hemodialysis Machine is indicated for patients with renal failure who require dialysis to remove waste and excess fluid from their blood. It is used in both acute and chronic kidney conditions.
Practical Considerations
The machine typically requires connection to a water source and power supply. It is compatible with standard dialysis tubing and filters. Clinicians should be trained in its operation and troubleshooting to ensure patient safety and effective treatment.
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 and excess fluid from the blood.
What specialties typically use this device?
Nephrology and dialysis specialties commonly use this device in both hospital and outpatient dialysis settings.
What are the FDA-cleared indications?
The device is indicated for use in patients with renal failure requiring dialysis to manage waste and fluid 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.