21 CFR 864.9125

§ 864.9125 Vacuum-assisted blood collection system.

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

Cite this

Citation: 21 CFR 864.9125, § 864.9125 Vacuum-assisted blood collection system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89409
Permanent ID: ys:prov:89409@1
SHA-256: efa15d323bcc47d4102ddd97dae2bdcf1f2752f692ca38b438e654cdee867bee

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Full text

(a) Identification. A vacuum-assisted blood collection system is a device intended for medical purposes that uses a vacuum to draw blood for subsequent reinfusion. (b) Classification. Class I (general controls). The manual device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.

Legislative history

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