Title 21

SECTION 864.9195

864.9195 Blood mixing devices and blood weighing devices.

§ 864.9195 Blood mixing devices and blood weighing devices.

(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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