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 Cryopreservati
| Device Type ID | 2435 |
| Device Name | Cryogenic Cord Blood Storage Container |
| 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 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 | OOF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |