Blood Establishment Computer Software, User Developed
Device Code: 2504
Product Code(s):
OYT 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.
Device Classification Information
| Device Type ID | 2504 |
| Device Name | Blood Establishment Computer Software, User Developed |
| Physical State | Solid |
| Technical Method | Software |
| Target Area | Blood Establishment |
| Review Panel | Hematology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(K) Exempt |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | OYT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 2504 |
| Device | Blood Establishment Computer Software, User Developed |
| Product Code | OYT |
TPLC Last Update: 2019-04-02 20:13:27