đź“‹ FDA Reference
deionizer and carbon exchange service for hemodialysis
Culligan Soft Water Service
Summary: The deionizer and carbon exchange service is used in hemodialysis to purify water, ensuring it meets safety standards for patient treatment. It is primarily used by nephrologists and dialysis centers.
FDA Clearance Information
Pathway
510K
Number
K082400 ↗
Decision Date
February 3, 2009
Product Code
FIP
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on February 3, 2009. Manufactured by Culligan Soft Water Service, it is classified as a Class 2 device under product code FIP.
What It Is
The deionizer and carbon exchange service is a water purification system used in hemodialysis. It removes ions and organic compounds from water, ensuring it is safe for use in dialysis machines. This process is crucial as impurities in water can lead to patient complications during dialysis.
Clinical Applications
This device is commonly used in dialysis centers and hospitals where hemodialysis is performed. It is essential for maintaining the quality of water used in dialysis, which is critical for patient safety. Nephrologists and dialysis technicians rely on this service to ensure compliance with water quality standards.
Indications for Use
The device is indicated for use in purifying water for hemodialysis, ensuring that the water meets the necessary safety and quality standards. It is essential for patients undergoing dialysis treatment.
Practical Considerations
The service typically involves regular maintenance and monitoring to ensure optimal performance. Compatibility with existing dialysis systems is crucial, and facilities should ensure proper sizing and installation to meet their specific needs.
Frequently Asked Questions
What is the deionizer and 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 centers primarily use this device to maintain water quality for dialysis.
What are the FDA-cleared indications?
The device is indicated for purifying water used in hemodialysis to meet safety and quality standards.
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.