 |
Code of Federal Regulations (Last Updated: July 5, 2024) |
 |
Title 21 - Food and Drugs |
|
Chapter I - Food and Drug Administration, Department of Health and Human Services |
|
SubChapter H - Medical Devices |
|
Part 864 - Hematology and Pathology Devices |
|
Subpart J - Products Used In Establishments That Manufacture Blood and Blood Products |
§ 864.9125 - Vacuum-assisted blood collection system.
Latest version.
-
§ 864.9125 Vacuum-assisted blood collection system.
(a) Identification. A vacuum-assisted blood collection system is a device intended for medical purposes that uses a vacuum to draw blood for subsequent reinfusion.
(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 60639, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]