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modified bio hemodialysis hd-1000 disp cart
Ash Medical Systems
Summary: The Modified Bio Hemodialysis HD-1000 Disp Cart is a dialysis device used for hemodialysis treatment in patients with renal failure. It is typically utilized by nephrologists and dialysis technicians in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K870270 ↗
Decision Date
February 25, 1987
Product Code
FKT
Device Class
Class 2
Evidence
0 studies
The Modified Bio Hemodialysis HD-1000 Disp Cart by Ash Medical Systems was cleared through the FDA 510(k) pathway on February 25, 1987. It is classified as a Class 2 device under product code FKT.
What It Is
The Modified Bio Hemodialysis HD-1000 Disp Cart is a medical device designed to facilitate hemodialysis, a process that filters waste and excess fluids from the blood when the kidneys are no longer able to perform these functions. The device operates by circulating the patient's blood through a dialyzer, where it is cleansed before being returned to the body. This system is crucial for patients with chronic kidney disease or acute kidney injury requiring renal replacement therapy.
Clinical Applications
This device is commonly used in hospital dialysis units and outpatient dialysis centers. It is primarily employed by nephrologists and dialysis nurses to provide life-sustaining treatment for patients with end-stage renal disease (ESRD). The HD-1000 Disp Cart is suitable for adult and pediatric patients who require regular hemodialysis sessions to manage their kidney function.
Indications for Use
The FDA-cleared indications for this device include its use in patients with renal failure who require hemodialysis. It is intended for those who need assistance in removing waste products and excess fluids from their bloodstream due to impaired kidney function.
Practical Considerations
Clinicians should ensure compatibility with existing dialysis infrastructure and consider the specific needs of their patient population, such as blood flow rates and dialyzer compatibility. Proper training in the setup and operation of the device is essential for safe and effective use.
Frequently Asked Questions
What is Modified Bio Hemodialysis HD-1000 Disp Cart used for?
It is used for hemodialysis treatment in patients with renal failure to filter waste and excess fluids from the blood.
What specialties typically use this device?
Nephrology and dialysis technicians primarily use this device in clinical settings.
What are the FDA-cleared indications?
The device is indicated for use in patients with renal failure requiring 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.