21 CFR § 864.9195
Blood mixing devices and blood weighing devices
June 25, 2020
(a) Identification. A blood mixing device is a device intended for medical purposes that is used to mix blood or blood components by agitation. A blood weighing device is a device intended for medical purposes that is used to weigh blood or blood components as they are collected.
(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.
[45 FR 60642, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]
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