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acute hemodialysis trays
Intermed
Summary: Acute hemodialysis trays are used in dialysis procedures to manage kidney failure. They are utilized by nephrologists and dialysis technicians in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K833139 ↗
Decision Date
December 22, 1983
Product Code
KNZ
Device Class
Class 2
Evidence
0 studies
The acute hemodialysis trays by Intermed were cleared through the FDA 510(k) pathway on December 22, 1983. They are classified as Class 2 devices under product code KNZ.
What It Is
Acute hemodialysis trays are pre-packaged kits containing the necessary components for performing hemodialysis, a procedure to filter waste and excess fluids from the blood when the kidneys are not functioning properly. These trays typically include items such as catheters, tubing, and dialyzers. The trays are designed to streamline the setup process, ensuring that all necessary components are sterile and readily available.
Clinical Applications
These trays are commonly used in hospital settings, dialysis centers, and sometimes in home care environments for patients with acute or chronic kidney failure. Nephrologists and dialysis nurses use them to perform hemodialysis, which is critical for patients with end-stage renal disease or acute kidney injury. The trays facilitate efficient and sterile dialysis sessions, which are essential for patient safety and treatment efficacy.
Indications for Use
The FDA indications for these trays include use in patients requiring hemodialysis due to kidney failure. They are suitable for both acute and chronic conditions where dialysis is necessary to manage fluid and electrolyte balance.
Practical Considerations
These trays come in various configurations to accommodate different patient sizes and dialysis machines. Compatibility with specific dialysis machines should be verified. Proper technique in setting up and maintaining sterility is crucial to prevent infections.
Frequently Asked Questions
What is acute hemodialysis trays used for?
They are used to perform hemodialysis, a procedure to filter waste from the blood in patients with kidney failure.
What specialties typically use this device?
Nephrologists and dialysis technicians commonly use these trays in hospital and dialysis center settings.
What are the FDA-cleared indications?
They are indicated for use in patients requiring hemodialysis due to kidney failure, including both acute and chronic conditions.
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.