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dbb-05 hemodialysis delivery system
Davita Clinical Research (Trri)
Summary: The dbb-05 hemodialysis delivery system is a medical device used for hemodialysis treatment in patients with renal failure. It is typically operated by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K023509 ↗
Decision Date
October 30, 2003
Product Code
KDI
Device Class
Class 2
Evidence
0 studies
The dbb-05 hemodialysis delivery system, manufactured by Davita Clinical Research, was cleared through the FDA 510(k) pathway on October 30, 2003. It is classified as a Class 2 device under product code KDI.
What It Is
The dbb-05 hemodialysis delivery system is a machine designed to perform hemodialysis, a process that filters waste and excess fluids from the blood when the kidneys are no longer able to do so. It works by circulating the patient's blood through a dialyzer, where it is cleaned before being returned to the body. This system is integral in managing patients with chronic kidney disease or acute kidney injury requiring renal replacement therapy.
Clinical Applications
This device is commonly used in dialysis centers and hospitals, primarily by nephrology specialists and trained dialysis nurses. It is essential for patients with end-stage renal disease (ESRD) who require regular hemodialysis sessions, typically three times a week. The dbb-05 is also used in acute care settings for patients with temporary kidney failure due to illness or injury.
Indications for Use
The dbb-05 hemodialysis delivery system is indicated for use in patients with renal failure who require hemodialysis to remove waste products and excess fluid from the blood. It is suitable for both chronic and acute conditions affecting kidney function.
Practical Considerations
The dbb-05 system is compatible with standard dialysis equipment and is available in various configurations to accommodate different patient sizes and treatment needs. Clinicians should ensure proper training in device operation and maintenance to optimize patient safety and treatment efficacy.
Frequently Asked Questions
What is dbb-05 hemodialysis delivery system used for?
It is used for performing hemodialysis in patients with renal failure to filter waste and excess fluids from the blood.
What specialties typically use this device?
Nephrologists and dialysis nurses typically use this device in dialysis centers and hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in patients with renal failure requiring hemodialysis to manage waste and fluid removal from the blood.
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.