Product code
ONM: Radiant infant warmer cabinet
FDA product code · Class II · General Hospital
Key facts
| Product code | ONM |
|---|---|
| Device | Radiant infant warmer cabinet |
| Device class | Class II |
| Regulation number | 880.5130 |
| Review panel | General Hospital |
| Medical specialty | General Hospital |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | The device is intended to provide an enclosure for storage of an radiant infant warmer. It may also provide a bassinet for use with the radiant infant warmer, and provide power to the infant radiant warmer. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None 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