CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES > SUBPART G—General Hospital and Personal Use Miscellaneous Devices (§880.6025 to §880.6992) > 880.6740—Vacuum-powered body fluid suction apparatus.

880.6740—Vacuum-powered body fluid suction apparatus.

(a) Identification. A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).
(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.

Code of Federal Regulations

[45 FR 69682-69737, Oct. 21, 1980, as amended at 63 FR 59229, Nov. 3, 1998]