part_subject: "GENERAL HOSPITAL AND PERSONAL USE DEVICES"
subpart_code: "G"
subpart_subject: "General Hospital and Personal Use Miscellaneous Devices"
section_number: "880.6100"
section_subject: "Ethylene oxide gas aerator cabinet."
cfr_reference: "21 CFR 880.6100"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 800 to 1299"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(a)Identification. An ethyene oxide gas aerator cabinet is a device that is intended for use by a health care provider and consists of a cabinet with a ventilation system designed to circulate and exchange the air in the cabinet to shorten the time required to remove residual ethylene oxide (ETO) from wrapped medical devices that have undergone ETO sterilization. The device may include a heater to warm the circulating air.
(b)Classification. Class II (performance standards).