QLF · On-Body Injector
General Hospital · 21 CFR 880.5860 · Class 2
Overview
| Product Code | QLF |
|---|---|
| Device Name | On-Body Injector |
| Regulation | 21 CFR 880.5860 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
