📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Purification of water used for hemodialysis.
- Removal of ionic contaminants and other impurities through deionization and carbon exchange before dialysis treatment.
Clinical Applications
- Treating water supplied to hemodialysis systems.
- Supporting water-quality control in hospital dialysis units.
- Supporting water-quality control in outpatient dialysis centers.
- Use by dialysis personnel as part of a hemodialysis water-treatment system.
Practical Considerations
- This is a facility water-treatment device, not an implantable or patient-contact device.
- Installation and compatibility should be confirmed with the dialysis machine, water supply, plumbing, and the facility's complete water-treatment system.
- Carbon and deionization components require monitoring, testing, servicing, and replacement according to manufacturer instructions and applicable dialysis water-quality requirements.
- The device does not replace routine microbiological, chemical, or endotoxin testing of dialysis water and dialysate systems.
- MRI safety is generally not a patient issue because the device is used in the dialysis water-treatment area; facilities should review the equipment's materials and location before placing it in an MRI-controlled area.
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.