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21 CFR 868.5830

§ 868.5830 Autotransfusion apparatus.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 868.5830, § 868.5830 Autotransfusion apparatus, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89839
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(a) Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma. (b) Classification. Class II (performance standards).

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.