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dayton water systems ultrapure water treatment systems for hemodialysis
Dayton Water Systems
Summary: The Dayton Water Systems Ultrapure Water Treatment Systems are designed for hemodialysis, ensuring the purity of water used in dialysis treatments. It is primarily used by nephrologists and dialysis technicians in clinical settings.
FDA Clearance Information
Pathway 510K
Number K021352 ↗
Decision Date August 1, 2002
Product Code FIP
Device Class Class 2
Evidence 0 studies
The device was cleared through the FDA 510(k) pathway on August 1, 2002, by Dayton Water Systems. It is classified as a Class 2 device under product code FIP.
What It Is
The Dayton Water Systems Ultrapure Water Treatment Systems are specialized devices used to purify water for hemodialysis. These systems remove contaminants and ensure that the water meets stringent quality standards necessary for patient safety during dialysis. The device typically includes components like filters and reverse osmosis units to achieve ultrapure water quality.
Clinical Applications
This device is commonly used in dialysis centers and hospitals where hemodialysis is performed. It is essential for nephrology departments to provide safe and effective dialysis treatment. The system is crucial for patients with end-stage renal disease who require regular dialysis, ensuring that the water used does not introduce any harmful substances into the bloodstream.
Indications for Use
The FDA-cleared indications for this device involve its use in treating water for hemodialysis. It is intended for patients undergoing dialysis treatment, ensuring the water used is free from contaminants that could harm the patient.
Practical Considerations
When using this system, ensure compatibility with existing dialysis equipment and follow maintenance protocols to maintain water quality. Regular monitoring of water purity is crucial, and the system should be sized appropriately for the volume of dialysis treatments performed.
Frequently Asked Questions
What is Dayton Water Systems Ultrapure Water Treatment Systems used for?
It is used to purify water for hemodialysis, ensuring the water meets safety standards for dialysis treatments.
What specialties typically use this device?
Nephrology and dialysis centers use this device, primarily operated by nephrologists and dialysis technicians.
What are the FDA-cleared indications?
The device is indicated for treating water used in hemodialysis to ensure it is free from harmful 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.