Definition: A Cord Blood Processing System And Storage Container Is A Device Intended For Use In The Processing And The Storage Of Cord Blood. This Device Is Used As A Functionally Closed Processing System By Cord Blood Establishments. This Device Includes Conta
| Device Type ID | 2431 |
| Device Name | Cord Blood Processing System And Storage Container |
| Physical State | X |
| Technical Method | X |
| Target Area | Blood Storage |
| Regulation Description | Cord Blood Processing System And Storage Container. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(k) |
| CFR Regulation Number | 864.9900 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OAO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2431 |
| Device | Cord Blood Processing System And Storage Container |
| Product Code | OAO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cord Blood Processing System And Storage Container. |
| CFR Regulation Number | 864.9900 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOSAFE SA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PALL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PALL EUROPE LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
THERMOGENESIS CORP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |