Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 8 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / 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.
§ 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.