Product code
PIO: Enteral specific transition connectors
FDA product code · Class II · Gastroenterology/Urology
Key facts
| Product code | PIO |
|---|---|
| Device | Enteral specific transition connectors |
| Device class | Class II |
| Regulation number | 876.5980 |
| Review panel | Gastroenterology/Urology |
| Medical specialty | Gastroenterology/Urology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Facilitates enteral specific connections between AAMI/CN3(PS):2014 compliant connectors and non ISO 80369-1 compliant legacy enteral connectors. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 100–999 MAUDE adverse event reports
- 1–9 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