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wro 300 water purification system for hemodialysis
Gambro Renal Products
Summary: The WRO 300 is a water purification system designed for hemodialysis, ensuring safe and clean water for dialysis treatments. It is primarily used by nephrologists and dialysis technicians in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K042797 ↗
Decision Date
March 9, 2005
Product Code
FIP
Device Class
Class 2
Evidence
0 studies
The WRO 300 water purification system by Gambro Renal Products was cleared through the FDA 510(k) pathway on March 9, 2005. It is classified as a Class 2 device under product code FIP.
What It Is
The WRO 300 is a water purification system specifically designed for use in hemodialysis. It removes contaminants and impurities from water, ensuring it meets the stringent quality standards required for dialysis. The system uses a combination of filtration and reverse osmosis to purify water, providing a reliable source of clean water necessary for safe dialysis treatments.
Clinical Applications
The WRO 300 is commonly used in dialysis centers and hospitals where hemodialysis is performed. It is essential for nephrology departments to ensure that the water used in dialysis is free from harmful substances. This device is crucial for patients with chronic kidney disease who require regular dialysis, as well as in acute settings where temporary dialysis may be needed.
Indications for Use
The WRO 300 is indicated for use in purifying water for hemodialysis treatments. It is essential for patients undergoing dialysis to prevent exposure to contaminants that could lead to complications.
Practical Considerations
The WRO 300 is compatible with standard dialysis equipment and is designed to integrate seamlessly into existing dialysis setups. Regular maintenance and monitoring are required to ensure optimal performance and water quality. It is important to follow manufacturer guidelines for installation and operation.
Frequently Asked Questions
What is the WRO 300 used for?
The WRO 300 is used to purify water for hemodialysis, ensuring it meets safety and quality standards for dialysis treatments.
What specialties typically use this device?
Nephrologists and dialysis technicians in nephrology departments and dialysis centers typically use this device.
What are the FDA-cleared indications?
The WRO 300 is indicated for purifying water for hemodialysis to ensure safe and effective dialysis treatments.
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.