21 C.F.R. § 868.1100

Current through September 30, 2024
Section 868.1100 - Arterial blood sampling kit
(a)Identification. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. The kit may include a syringe, needle, cork, and heparin.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9 .

21 C.F.R. §868.1100

47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38793, July 25, 2001