21 CFR § 864.9100
Empty container for the collection and processing of blood and blood components
June 25, 2020
(a) Identification. An empty container for the collection and processing of blood and blood components is a device intended for medical purposes that is an empty plastic bag or plastic or glass bottle used to collect, store, or transfer blood and blood components for further processing.
(b) Classification. Class II (performance standards).
[45 FR 60638, Sept. 12, 1980]
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