[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR880.5570]

[Page 385]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES--Table of Contents
 
    Subpart F--General Hospital and Personal Use Therapeutic Devices
 
Sec. 880.5570  Hypodermic single lumen needle.

    (a) Identification. A hypodermic single lumen needle is a device 
intended to inject fluids into, or withdraw fluids from, parts of the 
body below the surface of the skin. The device consists of a metal tube 
that is sharpened at one end and at the other end joined to a female 
connector (hub) designed to mate with a male connector (nozzle) of a 
piston syringe or an intravascular administration set.
    (b) Classification. Class II (performance standards).