21 C.F.R. § 864.9195 Blood mixing devices and blood weighing devices.
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products
§ 864.9195 Blood mixing devices and blood weighing devices.
