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2008t hemodialysis machine with optional crit-line monitor clic
Fresenius Medical Care Renal Therapies Group
Summary: The 2008t hemodialysis machine with optional Crit-Line monitor is used for dialysis treatment in patients with kidney failure. It is primarily used by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K131908 ↗
Decision Date
October 11, 2013
Product Code
KDI
Device Class
Class 2
Evidence
0 studies
The 2008t hemodialysis machine was cleared through the FDA 510(k) pathway on October 11, 2013. Manufactured by Fresenius Medical Care Renal Therapies Group, it is a Class 2 device under product code KDI.
What It Is
The 2008t hemodialysis machine is a medical device designed to perform hemodialysis, a process that filters waste and excess fluids from the blood when the kidneys are not functioning properly. It includes an optional Crit-Line monitor that provides real-time data on hematocrit, oxygen saturation, and blood volume changes. This device is essential in managing patients with end-stage renal disease (ESRD) and acute kidney injury requiring dialysis.
Clinical Applications
The 2008t hemodialysis machine is commonly used in dialysis centers and hospitals. It is essential for nephrologists and dialysis nurses when treating patients with chronic kidney disease or acute renal failure. The machine is suitable for adult and pediatric patients requiring regular dialysis sessions. It is also used in home dialysis settings for patients who have been trained to perform dialysis independently.
Indications for Use
The FDA indications for the 2008t hemodialysis machine include its use in patients with kidney failure who require dialysis to remove waste products and excess fluid from the blood. It is indicated for both chronic and acute renal conditions.
Practical Considerations
The 2008t machine is compatible with various dialysis access types, including fistulas, grafts, and catheters. It is important to ensure proper machine calibration and maintenance for optimal performance. Clinicians should be trained in its operation and troubleshooting to ensure patient safety.
Frequently Asked Questions
What is the 2008t hemodialysis machine used for?
It is used for performing hemodialysis to filter waste and excess fluids from the blood in patients with kidney failure.
What specialties typically use this device?
Nephrologists and dialysis nurses primarily use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
It is indicated for use in patients with kidney failure requiring dialysis to remove waste and excess fluid 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.