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hd-100 hemodialysis systems and accessories
Water Pure
Summary: The hd-100 hemodialysis system by Water Pure is a medical device used for dialysis treatment in patients with kidney failure. It is primarily used by nephrologists and dialysis technicians in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K863720 ↗
Decision Date
October 29, 1986
Product Code
FIP
Device Class
Class 2
Evidence
0 studies
The hd-100 hemodialysis system was cleared through the FDA 510(k) pathway on October 29, 1986. Manufactured by Water Pure, it is classified as a Class 2 device under product code FIP.
What It Is
The hd-100 hemodialysis system 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 consists of a machine and various accessories that facilitate the dialysis process by circulating the patient's blood through a dialyzer. This system is essential for patients with chronic kidney disease or acute kidney failure.
Clinical Applications
The hd-100 is commonly used in dialysis centers and hospitals for patients requiring regular hemodialysis treatments. It is primarily used by nephrologists, dialysis nurses, and technicians. The device is suitable for adult and pediatric patients who need renal replacement therapy due to end-stage renal disease or acute kidney injury.
Indications for Use
The hd-100 is indicated for patients with kidney failure who require hemodialysis to remove waste products and excess fluid from their blood. It is suitable for those with chronic kidney disease or acute kidney injury who cannot effectively filter their blood naturally.
Practical Considerations
When using the hd-100, clinicians should ensure compatibility with the patient's vascular access and consider the appropriate dialyzer size based on the patient's body size and treatment needs. Regular maintenance and calibration of the system are essential for optimal performance.
Frequently Asked Questions
What is the hd-100 hemodialysis system used for?
The hd-100 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?
Nephrologists and dialysis technicians 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 kidney failure who require hemodialysis to remove waste products and excess fluids from their 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.