Product Overview:
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Type: Assist Header Cleaner
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Packaging: 50 cleaners per bag (50/BAG)
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Function: Designed to clean dialyzer headers effectively without the risk of damaging dialyzer fibers.
Key Features:
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Enhanced Rinsing Process: The Assist Header Cleaner is designed to enhance the rinsing process of dialyzer headers by directing two lateral jets of Reverse Osmosis (RO) water, effectively dislodging residual blood and debris from multiple-use hemodialyzers.
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Thorough Cleaning: Ensures a thorough cleaning of header spaces and header caps, making it easier to prepare dialyzers for approved reprocessing procedures.
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AAMI Standards Compliant: Fully compliant with the AAMI standards for the reuse of hemodialyzers (RD47:2002), ensuring it meets the necessary safety and operational guidelines.
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FDA 510K Clearance: The Assist Header Cleaner has received FDA 510K clearance as a medical device, ensuring it meets the regulatory requirements for use in healthcare settings.
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Preserves Dialyzer Fibers: Specifically designed to clean headers without causing damage to the sensitive dialyzer fibers, ensuring the longevity and performance of the dialyzer.
Intended Use:
The Assist Header Cleaner is intended for use in hemodialysis centers to clean and prepare dialyzers for reuse. By ensuring a thorough and effective cleaning process, it helps maintain the quality and safety of the dialyzers, in compliance with regulatory standards.
