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isopure complete water system for hemodialysis md 400 and md 600 series
Isopure
Summary: The Isopure Complete Water System for Hemodialysis is a device used to purify water for dialysis treatments. It is primarily used by nephrologists and dialysis technicians in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K041163 ↗
Decision Date
October 7, 2004
Product Code
FIP
Device Class
Class 2
Evidence
0 studies
The Isopure Complete Water System was cleared through the FDA 510k pathway on October 7, 2004. Manufactured by Isopure, it is classified as a Class 2 device under product code FIP.
What It Is
The Isopure Complete Water System is designed to provide high-quality water for hemodialysis treatments. It removes impurities and contaminants from water, ensuring it meets the stringent standards required for dialysis. This system is crucial in preventing complications that can arise from impure water during dialysis sessions.
Clinical Applications
This device is commonly used in dialysis centers and hospitals where hemodialysis is performed. It is essential for nephrology departments, ensuring that patients with kidney failure receive safe and effective dialysis treatment. The system is used for adult and pediatric patients requiring dialysis, providing consistent water quality across different settings.
Indications for Use
The Isopure Complete Water System is indicated for use in purifying water for hemodialysis, ensuring it is free from harmful contaminants. It is suitable for patients undergoing dialysis, particularly those with chronic kidney disease or acute kidney injury.
Practical Considerations
The system is typically compatible with standard dialysis machines and requires regular maintenance to ensure optimal performance. Clinicians should be aware of the system's capacity and ensure it meets the demands of their specific clinical setting.
Frequently Asked Questions
What is the Isopure Complete Water System used for?
It is used to purify water for hemodialysis treatments, ensuring the water meets safety standards.
What specialties typically use this device?
Nephrology and dialysis centers primarily use this device.
What are the FDA-cleared indications?
The device is indicated for purifying water for use in hemodialysis, ensuring it is safe and free from contaminants.
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.