Product code
OYT: Blood establishment computer software, user developed
FDA product code · Unclassified · Hematology
Key facts
| Product code | OYT |
|---|---|
| Device | Blood establishment computer software, user developed |
| Device class | Unclassified |
| Review panel | Hematology |
| Submission type | 510(K) Exempt |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | To store information that blood establishement personnel use to make decisions concerning the suitability of blood and blood products for further manufacture or transfusion. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- 1–9 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