(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]