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acute hemodialysis trays
Packaging Technologies
Summary: Acute hemodialysis trays are used in dialysis procedures to manage acute kidney failure. They are typically utilized by nephrologists and dialysis nurses in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K844612 ↗
Decision Date
December 17, 1984
Product Code
KNZ
Device Class
Class 2
Evidence
0 studies
The acute hemodialysis trays by Packaging Technologies were cleared through the FDA 510(k) pathway on December 17, 1984. This device is classified as a Class 2 medical device under product code KNZ.
What It Is
Acute hemodialysis trays are pre-packaged kits containing all necessary components for performing hemodialysis, a procedure to filter waste and excess fluid from the blood when the kidneys are not functioning properly. These trays help streamline the setup process, ensuring that all required tools are readily available and sterile. They are designed for use in acute settings where rapid intervention is needed.
Clinical Applications
These trays are commonly used in hospital settings, particularly in intensive care units and emergency departments, where patients with acute kidney injury require immediate dialysis. They are essential for nephrologists and dialysis nurses who perform dialysis in patients with sudden loss of kidney function. The trays facilitate quick and efficient dialysis setup, which is critical in acute care scenarios.
Indications for Use
The FDA indications suggest that these trays are intended for use in patients experiencing acute kidney failure, where immediate dialysis is necessary to manage waste and fluid levels in the blood. They are suitable for patients who require temporary dialysis support.
Practical Considerations
Clinicians should ensure compatibility with existing dialysis machines and verify the tray's contents before use. Typical sizing and components may vary, so familiarity with the specific tray configuration is recommended. Proper technique in setting up and using the tray is essential for effective dialysis treatment.
Frequently Asked Questions
What is acute hemodialysis trays used for?
They are used for performing hemodialysis in patients with acute kidney failure.
What specialties typically use this device?
Nephrologists and dialysis nurses in hospital settings, especially in ICUs and emergency departments.
What are the FDA-cleared indications?
For use in patients with acute kidney failure requiring immediate dialysis.
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.