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asi deionizer carbon exchange service for hemodialysis
Aqua Sciences
Summary: The asi deionizer carbon exchange service is a device used in hemodialysis to purify water by removing impurities. It is primarily used by nephrologists and dialysis technicians in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K102892 ↗
Decision Date
February 3, 2011
Product Code
FIP
Device Class
Class 2
Evidence
0 studies
The asi deionizer carbon exchange service was cleared through the FDA 510(k) pathway on February 3, 2011. Manufactured by Aqua Sciences, this device is classified as Class 2 under product code FIP.
What It Is
The asi deionizer carbon exchange service is a water purification system designed for use in hemodialysis. It works by removing ions and other impurities from water through a process of deionization and carbon exchange, ensuring the water meets the stringent quality standards required for dialysis. This is crucial for patient safety, as impure water can lead to serious complications during dialysis treatment.
Clinical Applications
This device is commonly used in dialysis centers and hospitals where hemodialysis is performed. It is essential for ensuring the water used in dialysis machines is free of harmful contaminants. Nephrologists, dialysis nurses, and technicians rely on this device to maintain the safety and efficacy of dialysis treatments for patients with kidney failure.
Indications for Use
The FDA-cleared indications for this device include its use in purifying water for hemodialysis. It is intended for patients undergoing dialysis, ensuring the water used is safe and free from contaminants that could harm patients.
Practical Considerations
The asi deionizer carbon exchange service should be compatible with most standard dialysis systems. Regular maintenance and monitoring are required 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 asi deionizer carbon exchange service used for?
It is used to purify water for hemodialysis, removing impurities to ensure patient safety during 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 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.