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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 ?
510(k)
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.
FDA-Cleared Indications
- Purification of water used for hemodialysis.
- Removal of dissolved ions and other water contaminants through carbon exchange and deionization.
- Use as part of a hemodialysis water-treatment system in healthcare facilities.
Clinical Applications
- Treating water supplied to hemodialysis equipment.
- Supporting water preparation in hospital dialysis units.
- Supporting water preparation in outpatient dialysis centers.
- Providing deionized water for hemodialysis applications when installed and operated according to the manufacturer’s instructions.
Practical Considerations
- The system must be compatible with the facility’s incoming water supply, pretreatment equipment, dialysis machines, and water-distribution loop.
- Available configurations and tank sizes may differ, including models identified as 60MAW, 1/2MAW, 3/6MAW, and 1/2 configurations; verify the exact model and capacity before installation.
- Carbon beds, deionizer beds, and associated filters require monitoring, testing, regeneration or replacement, and preventive maintenance according to the manufacturer’s instructions and applicable dialysis-water standards.
- This is extracorporeal water-treatment equipment, not an implantable or patient-contact device; MRI compatibility is generally not the relevant safety classification, but nearby electrical and metal equipment should be managed according to facility policy.
- Water quality should be verified before use for dialysis, and the system should not be used if testing, alarms, resin exhaustion indicators, leaks, or other maintenance requirements show that treatment performance is inadequate.
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.