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monitral s gs hemodialysis single patient unit
Hospal Medical
Summary: The Monitral S GS is a hemodialysis unit designed for single-patient use, primarily utilized in dialysis centers and hospitals. It is used by nephrologists and dialysis nurses to manage patients with renal failure requiring hemodialysis.
FDA Clearance Information
Pathway
510K
Number
K871218 ↗
Decision Date
April 30, 1987
Product Code
FKP
Device Class
Class 2
Evidence
0 studies
The Monitral S GS Hemodialysis Unit was cleared through the FDA 510(k) pathway on April 30, 1987. Manufactured by Hospal Medical, it is classified as a Class 2 device under product code FKP.
What It Is
The Monitral S GS is a hemodialysis device intended for single-patient use. It facilitates the removal of waste products and excess fluid from the blood when the kidneys are not functioning properly. The device operates by circulating the patient's blood through a dialyzer, which acts as an artificial kidney. This process is crucial for patients with chronic kidney disease or acute kidney injury.
Clinical Applications
This device is commonly used in nephrology departments, dialysis centers, and hospitals. It is essential for managing patients with end-stage renal disease (ESRD) who require regular dialysis sessions. The unit is also used in acute settings for patients with temporary kidney failure. It serves a critical role in maintaining electrolyte balance and preventing complications associated with renal failure.
Indications for Use
The Monitral S GS is indicated for patients with kidney failure who need hemodialysis to remove toxins and excess fluids from their blood. It is suitable for both chronic and acute renal failure conditions.
Practical Considerations
The device is typically compatible with standard dialysis access points, such as AV fistulas or catheters. Clinicians should ensure proper setup and monitoring during use to prevent complications. Regular maintenance and calibration are necessary for optimal performance.
Frequently Asked Questions
What is Monitral S GS Hemodialysis Unit used for?
It is used for performing hemodialysis in patients with kidney failure to remove waste and excess fluid from the blood.
What specialties typically use this device?
Nephrology and dialysis nursing specialties commonly use this device in dialysis centers and hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in patients with renal failure requiring hemodialysis to manage waste and fluid balance.
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.