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aiw water system for hemodialysis
American Industrial Water
Summary: The AIW Water System for Hemodialysis is designed to purify water for use in hemodialysis treatments. It is used by nephrologists and dialysis technicians to ensure safe and effective dialysis sessions for patients with renal failure.
FDA Clearance Information
Pathway
510K
Number
K001282 ↗
Decision Date
December 15, 2000
Product Code
FIP
Device Class
Class 2
Evidence
0 studies
The AIW Water System for Hemodialysis was cleared through the FDA 510k pathway on December 15, 2000. It is manufactured by American Industrial Water and is classified as a Class 2 medical device.
What It Is
The AIW Water System for Hemodialysis is a water purification system specifically designed for use in hemodialysis. It removes contaminants and impurities from water to meet the stringent quality standards required for dialysis treatments. This system ensures that the water used in dialysis is free from harmful substances that could affect patient safety and treatment efficacy.
Clinical Applications
This device is commonly used in dialysis centers and hospitals where hemodialysis is performed. It is essential for the treatment of patients with chronic kidney disease or acute renal failure who require dialysis. Nephrologists, dialysis nurses, and technicians rely on this system to provide safe dialysis treatments, ensuring that the water quality meets the necessary standards for patient care.
Indications for Use
The AIW Water System is indicated for use in purifying water for hemodialysis treatments. It is essential for patients undergoing dialysis due to kidney failure, ensuring that the water used is free from contaminants.
Practical Considerations
The system should be compatible with standard dialysis equipment and requires regular maintenance to ensure optimal performance. It is important to follow manufacturer guidelines for installation and operation to maintain water quality standards.
Frequently Asked Questions
What is the AIW Water System for Hemodialysis used for?
It is used to purify water for hemodialysis treatments, ensuring the water meets safety and quality standards.
What specialties typically use this device?
Nephrology and dialysis centers use this device, often operated by nephrologists and dialysis technicians.
What are the FDA-cleared indications?
It is indicated for purifying water for use in hemodialysis treatments to ensure patient safety and treatment efficacy.
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.