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hemodialysis concentrate sodiu
Renal Systems
Summary: The hemodialysis concentrate sodiu by Renal Systems is a medical device used in the process of hemodialysis to help filter waste from the blood. It is primarily used by nephrologists and dialysis technicians in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K781967 ↗
Decision Date
December 7, 1978
Product Code
KPO
Device Class
Class 2
Evidence
0 studies
The hemodialysis concentrate sodiu was cleared through the FDA 510k pathway on December 7, 1978. Manufactured by Renal Systems, this device is classified as a Class 2 medical device under product code KPO.
What It Is
The hemodialysis concentrate sodiu is a solution used in hemodialysis machines to help remove waste products and excess fluids from the blood of patients with renal failure. It works by balancing electrolytes and maintaining the correct pH in the dialysis fluid, which is crucial for effective dialysis treatment. This concentrate is mixed with purified water to create the dialysate solution used during the hemodialysis procedure.
Clinical Applications
This device is commonly used in dialysis centers and hospitals where patients with chronic kidney disease or acute kidney injury receive hemodialysis treatment. Nephrologists and dialysis nurses typically oversee its use. It is essential for maintaining the chemical balance in the blood of patients undergoing dialysis, ensuring that waste products and excess fluids are effectively removed.
Indications for Use
The hemodialysis concentrate sodiu is indicated for use in patients with kidney failure who require hemodialysis to filter waste and excess fluids from their blood. It is suitable for both chronic and acute renal failure patients who are undergoing dialysis treatment.
Practical Considerations
The concentrate is typically available in various formulations to match specific patient needs and dialysis machine requirements. It must be used with compatible dialysis machines and mixed accurately with purified water to ensure patient safety and treatment efficacy. Regular monitoring of electrolyte levels is advised during its use.
Frequently Asked Questions
What is hemodialysis concentrate sodiu used for?
It is used in the hemodialysis process to help filter waste and excess fluids from the blood of patients with kidney failure.
What specialties typically use this device?
Nephrologists and dialysis technicians in dialysis centers and hospitals typically use this device.
What are the FDA-cleared indications?
It is indicated for use in patients with kidney failure who require hemodialysis to filter waste and excess fluids from their blood.
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.