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modification to ameriwater purification system for hemodialysis
Ameriwater
Summary: The Ameriwater Purification System is a medical device used in hemodialysis to ensure water purity. It is primarily used by nephrologists and dialysis technicians in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K021560 ↗
Decision Date
August 14, 2003
Product Code
FIP
Device Class
Class 2
Evidence
0 studies
The Ameriwater Purification System was cleared through the FDA 510k pathway on August 14, 2003. It is manufactured by Ameriwater and classified as a Class 2 device.
What It Is
The Ameriwater Purification System is designed to purify water for hemodialysis, ensuring that the water meets specific safety and quality standards. It removes contaminants and impurities that could harm patients undergoing dialysis. The system typically includes components such as filters, reverse osmosis units, and deionizers, which work together to produce water that is safe for dialysis use.
Clinical Applications
This device is commonly used in dialysis centers and hospitals where hemodialysis is performed. Nephrologists and dialysis technicians rely on it to provide safe and effective treatment for patients with kidney failure. It is crucial for maintaining the quality of dialysis treatment, particularly for patients who require regular dialysis sessions.
Indications for Use
The FDA-cleared indications for this device involve its use in purifying water for hemodialysis. It is essential for patients with chronic kidney disease who need dialysis to remove waste products and excess fluid from their blood.
Practical Considerations
The system may come in different sizes to accommodate various facility needs, and it should be compatible with standard dialysis machines. Regular maintenance and monitoring are necessary to ensure optimal performance and water quality.
Frequently Asked Questions
What is Ameriwater Purification System used for?
It is used to purify water for hemodialysis, ensuring it meets safety and quality standards for patient treatment.
What specialties typically use this device?
Nephrology and dialysis technicians in clinical settings such as dialysis centers and hospitals.
What are the FDA-cleared indications?
The device is indicated for purifying water used in hemodialysis 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.