Product code
QLF: On-body injector
FDA product code · Class II · General Hospital
Key facts
| Product code | QLF |
|---|---|
| Device | On-body injector |
| Device class | Class II |
| Regulation number | 880.5860 |
| Review panel | General Hospital |
| Medical specialty | General Hospital |
| Submission type | Contact ODE |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | An On-Body injector is a prescription device adhered to the body intended to inject single or multiple doses of medicinal product from a cartridge or reservoir in accordance with FDA approved labeling. The device can be used by health care professionals or for self-injection by the patient. It should not be used for the infusion of drugs. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- None MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database