đź“‹ FDA Reference
biologic 1000 hemodialysis mach hd-1000 disp cartr
Ash Medical Systems
Summary: The Biologic 1000 Hemodialysis Mach HD-1000 is a hemodialysis machine used for renal replacement therapy in patients with kidney failure. It is primarily used by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K864179 ↗
Decision Date
December 11, 1986
Product Code
FKT
Device Class
Class 2
Evidence
0 studies
The Biologic 1000 Hemodialysis Mach HD-1000 was cleared via the FDA 510k pathway on December 11, 1986. Manufactured by Ash Medical Systems, it is classified as a Class 2 device under product code FKT.
What It Is
The Biologic 1000 Hemodialysis Mach HD-1000 is a medical device designed to perform hemodialysis, a process that filters waste products and excess fluids from the blood when the kidneys are no longer able to do so. It operates by diverting blood from the patient into the machine, where it is cleaned before being returned to the body. This device is essential in managing chronic kidney disease and acute kidney injuries.
Clinical Applications
This device is commonly used in hospital dialysis units and outpatient dialysis centers. It is essential for patients with end-stage renal disease (ESRD) requiring regular dialysis sessions. Nephrologists and dialysis nurses typically operate this machine, ensuring proper setup and monitoring during the procedure. It serves a critical role in maintaining the health and quality of life for patients awaiting kidney transplants or those not eligible for transplantation.
Indications for Use
The FDA indications for this device include its use in patients with chronic kidney disease or acute kidney injury requiring hemodialysis. It is suitable for individuals who need regular blood filtration due to insufficient kidney function.
Practical Considerations
The Biologic 1000 Hemodialysis Mach HD-1000 is compatible with standard dialysis cartridges and tubing. Clinicians should ensure proper calibration and maintenance of the machine for optimal performance. Familiarity with the device's settings and alarms is crucial for safe operation.
Frequently Asked Questions
What is Biologic 1000 Hemodialysis Mach HD-1000 used for?
It is used for performing hemodialysis in patients with kidney failure to filter waste and excess fluids 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 with chronic kidney disease or acute kidney injury 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.