21 CFR 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.
Title 21 published on 2015-12-03
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 864 after this date.
Title 21 published on 2015-12-03.
No entries appear in the Federal Register after this date, for 21 CFR Part 864.