GUARDED NEEDLE 2000
Device Facts
| Record ID | K003406 |
|---|---|
| Device Name | GUARDED NEEDLE 2000 |
| Applicant | International Medical Device Partners, Inc. |
| Product Code | FMI · General Hospital |
| Decision Date | Jan 12, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5570 |
| Device Class | Class 2 |
Regulatory Classification
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.
