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cobe c hemodialysis delivery system cobe cartridge blood tubing set
Gambro Healthcare
Summary: The Cobe C Hemodialysis Delivery System by Gambro Healthcare is a medical device used for hemodialysis treatment in patients with renal failure. It is primarily used by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K982760 ↗
Decision Date
November 4, 1998
Product Code
KDI
Device Class
Class 2
Evidence
0 studies
The Cobe C Hemodialysis Delivery System was cleared through the FDA 510(k) pathway on November 4, 1998. Manufactured by Gambro Healthcare, it is classified as a Class 2 device under product code KDI.
What It Is
The Cobe C Hemodialysis Delivery System is a medical device designed to perform hemodialysis, a process that filters waste products and excess fluids from the blood when the kidneys are not functioning properly. It includes a delivery system and a cartridge blood tubing set, which facilitate the safe and efficient exchange of blood and dialysate. The system is engineered to ensure precise control over dialysis parameters, enhancing patient safety and treatment efficacy.
Clinical Applications
This device is commonly used in hospital dialysis units and outpatient dialysis centers. It is essential for managing patients with chronic kidney disease (CKD) or acute kidney injury (AKI) requiring renal replacement therapy. Nephrologists, dialysis nurses, and technicians use this system to provide life-sustaining treatment to patients, ensuring the removal of toxins and fluid balance in the body.
Indications for Use
The FDA-cleared indications for the Cobe C Hemodialysis Delivery System include its use in patients requiring hemodialysis due to kidney failure. It is suitable for both chronic and acute conditions where dialysis is necessary to manage renal function.
Practical Considerations
The Cobe C Hemodialysis Delivery System is compatible with standard dialysis cartridges and blood tubing sets. It is important to ensure proper setup and calibration before use to maintain treatment accuracy. Regular maintenance and adherence to manufacturer guidelines are crucial for optimal performance.
Frequently Asked Questions
What is the Cobe C Hemodialysis Delivery System used for?
It is used for performing hemodialysis in patients with kidney failure to remove waste products and excess fluid from the blood.
What specialties typically use this device?
Nephrology and dialysis nursing specialties typically use this device in clinical settings.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring hemodialysis due to kidney failure, both chronic and acute.
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.