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ameriwater purification system for hemodialysis
Ameriwater
Summary: The Ameriwater Purification System is used in hemodialysis to ensure water quality. It is essential for nephrologists and dialysis centers to maintain safe dialysis conditions.
FDA Clearance Information
Pathway
510K
Number
K991519 ↗
Decision Date
April 14, 2000
Product Code
FIP
Device Class
Class 2
Evidence
0 studies
The Ameriwater Purification System was cleared via the FDA 510(k) pathway on April 14, 2000. Manufactured by Ameriwater, it is classified as a Class 2 device under product code FIP.
What It Is
The Ameriwater Purification System is a medical device designed to purify water for hemodialysis. It removes contaminants and ensures that the water meets the stringent quality standards required for dialysis treatment. By preventing exposure to harmful substances, it plays a crucial role in patient safety during dialysis sessions.
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 patients with safe and effective dialysis treatment. It is particularly important in settings where water quality may be compromised, such as during boil water advisories.
Indications for Use
The device is indicated for use in purifying water for hemodialysis, ensuring that patients with kidney failure receive treatment with water that is free from harmful contaminants. It is essential for maintaining the safety and efficacy of dialysis procedures.
Practical Considerations
The system must be compatible with existing dialysis equipment and adhere to local water quality standards. Regular maintenance and monitoring are crucial to ensure its effective operation. Clinicians should be aware of the specific installation and operational requirements.
Related Literature
The study titled 'Surviving a boil water advisory in dialysis and Y2K chlorination' from 2000 discusses the challenges faced during a boil water advisory and the importance of water purification systems in dialysis settings. Although the abstract is not available, the study likely highlights the critical role of reliable water purification in maintaining patient safety during such events. Limitations may include the lack of detailed data and specific outcomes.
Frequently Asked Questions
What is the Ameriwater Purification System used for?
It is used to purify water for hemodialysis, ensuring it is free from harmful contaminants.
What specialties typically use this device?
Nephrology and dialysis centers typically use this device to ensure safe dialysis treatment.
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.