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fresenius viral blocking transducer protector for hemodialysis model 04-9500-2
Fresenius Medical Care North America
Summary: The Fresenius Viral Blocking Transducer Protector is a device used in hemodialysis to prevent viral contamination. It is primarily used by nephrologists and dialysis technicians in dialysis centers.
FDA Clearance Information
Pathway
510K
Number
K003445 ↗
Decision Date
December 1, 2000
Product Code
FIB
Device Class
Class 2
Evidence
0 studies
The Fresenius Viral Blocking Transducer Protector was cleared through the FDA 510(k) pathway on December 1, 2000. It is manufactured by Fresenius Medical Care North America and classified as a Class 2 device.
What It Is
The Fresenius Viral Blocking Transducer Protector is designed to prevent viral contamination during hemodialysis by acting as a barrier between the dialysis machine and the patient. It works by filtering out potential viral particles, thereby reducing the risk of infection. This device is essential in maintaining the sterility of the dialysis process.
Clinical Applications
This device is commonly used in dialysis centers during hemodialysis sessions. It is particularly important in settings where infection control is critical, such as in patients with compromised immune systems. Nephrologists and dialysis technicians use this device to ensure safe and effective dialysis treatment for patients with chronic kidney disease.
Indications for Use
The device is indicated for use in hemodialysis to prevent viral contamination. It is suitable for patients undergoing dialysis who require protection from potential viral infections.
Practical Considerations
The Fresenius Viral Blocking Transducer Protector is compatible with standard hemodialysis machines. Clinicians should ensure proper installation and regular checks to maintain its efficacy. It is important to follow manufacturer guidelines for optimal performance.
Frequently Asked Questions
What is the Fresenius Viral Blocking Transducer Protector used for?
It is used to prevent viral contamination during hemodialysis.
What specialties typically use this device?
Nephrology and dialysis technicians in dialysis centers.
What are the FDA-cleared indications?
The device is indicated for preventing viral contamination in hemodialysis.
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.