[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR868.1100]

[Page 296]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 868_ANESTHESIOLOGY DEVICES--Table of Contents
 
                      Subpart B_Diagnostic Devices
 
Sec. 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 Sec. 868.9.

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