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pack h hemodialysis urea kinetic modeling software program
Fresenius U
Summary: The Pack H Hemodialysis Urea Kinetic Modeling Software by Fresenius U is used to optimize dialysis treatment by modeling urea kinetics. It is primarily used by nephrologists and dialysis technicians to enhance patient care.
FDA Clearance Information
Pathway
510K
Number
K955423 ↗
Decision Date
June 13, 1996
Product Code
FKP
Device Class
Class 2
Evidence
0 studies
The Pack H software was cleared through the FDA 510(k) pathway on June 13, 1996, by Fresenius U. It is classified as a Class 2 device under product code FKP.
What It Is
The Pack H Hemodialysis Urea Kinetic Modeling Software is a specialized program designed to assist in the management of hemodialysis treatment. It uses urea kinetic modeling to calculate and optimize dialysis dose, ensuring effective removal of waste products from the blood. This software supports clinicians in tailoring dialysis sessions to individual patient needs, improving treatment outcomes.
Clinical Applications
This software is commonly used in nephrology departments and dialysis centers. It is particularly valuable in settings where precise dialysis dosing is critical, such as in patients with fluctuating fluid and waste levels. Nephrologists and dialysis technicians utilize this tool to adjust treatment parameters, ensuring that each session is as effective as possible for patients with chronic kidney disease.
Indications for Use
The software is indicated for use in patients undergoing hemodialysis to assist in the calculation of dialysis dosing. It is particularly beneficial for patients with chronic kidney disease who require regular dialysis sessions to manage their condition.
Practical Considerations
The software is compatible with a range of dialysis machines and integrates with existing clinical workflows. It is important for users to be familiar with urea kinetic modeling principles to maximize the software's effectiveness. Regular updates and calibration may be necessary to maintain accuracy.
Frequently Asked Questions
What is Pack H Hemodialysis Urea Kinetic Modeling Software used for?
It is used to optimize dialysis treatment by modeling urea kinetics, helping to calculate and adjust dialysis dosing for effective waste removal.
What specialties typically use this device?
Nephrologists and dialysis technicians commonly use this software in nephrology departments and dialysis centers.
What are the FDA-cleared indications?
The software is indicated for use in calculating dialysis dosing for patients undergoing hemodialysis, particularly those with chronic kidney disease.
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.