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hemodialysis carbon exchange dual bed deionizer exchange mixed bed deionizer exchange model 60maw 1 2maw 3 6maw 1 2
New Aqua, Llc (Dba Aqua Systems)
Summary: The hemodialysis carbon exchange dual bed deionizer is a device used in dialysis to purify water for hemodialysis treatments. It is primarily used by nephrologists and dialysis technicians.
FDA Clearance Information
Pathway
510K
Number
K092481 ↗
Decision Date
April 2, 2010
Product Code
FIP
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on April 2, 2010. It is manufactured by New Aqua, LLC and classified as a Class 2 device under product code FIP.
What It Is
This device is a water purification system specifically designed for use in hemodialysis. It employs a dual bed deionizer and mixed bed deionizer to remove impurities and ions from water, ensuring the water used in dialysis is safe and meets clinical standards. The system is essential for maintaining the quality of dialysis treatments by preventing contamination and ensuring patient safety.
Clinical Applications
The hemodialysis carbon exchange deionizer is commonly used in dialysis centers and hospitals where hemodialysis is performed. It is crucial for preparing water that meets the stringent requirements for dialysis, making it indispensable in nephrology departments. The device is used for patients with end-stage renal disease who require regular dialysis treatments.
Indications for Use
The device is indicated for use in purifying water for hemodialysis, making it suitable for patients undergoing dialysis due to kidney failure. It ensures that the water used in these treatments is free from harmful contaminants.
Practical Considerations
When using this device, consider the compatibility with existing dialysis systems and ensure regular maintenance for optimal performance. The device may come in various sizes to accommodate different facility needs, and proper installation is crucial for effective operation.
Frequently Asked Questions
What is the hemodialysis carbon exchange deionizer used for?
It is used to purify water for hemodialysis treatments, ensuring the water is safe and free from contaminants.
What specialties typically use this device?
Nephrologists and dialysis technicians in dialysis centers and hospitals.
What are the FDA-cleared indications?
The device is indicated for purifying water used in hemodialysis treatments for patients with kidney failure.
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.