| Device |
cryogenic cord blood storage container |
| Regulation Description |
Cord blood processing system and storage container. |
| Definition |
Intended as a final container for the cryopreservation and the storage of cord blood products. A cryogenic cord blood storage container is a flexible ethylene vinyl acetate (eva) or similar polymer bag intended as a final container for cryopreservation and storage of cord blood products in the liquid or vapor phases of liquid nitrogen. |
| Physical State |
Consists of flexible ethylene vinyl acetate (EVA) or similar polymer bag. May include sterile fluid path and access ports and is designed to withstand freezing in the liquid and vapor phases of liquid nitrogen. |
| Technical Method |
Acts as a physical container for cord blood products, and is designed to withstand freezing in the liquid and vapor phases of liquid nitrogen |
| Target Area |
Cord blood is collected from neonatal umbilical cord and stored for later infusion, injection or transplantation |
| Regulation Medical Specialty |
Hematology |
| Review Panel |
Hematology |
|---|
| Product Code | OOF |
|---|
| Premarket Review |
Center for Biologics Evaluation & Research (CBER)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
864.9900
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
