| Primary Device ID | 00861880000326 |
| NIH Device Record Key | 9f63526d-551f-4c38-9c7f-b16231ee918e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PrepaCyte-CB |
| Version Model Number | PCB2100-270 |
| Catalog Number | P/N PCB2100-270 |
| Company DUNS | 626132575 |
| Company Name | CRYO-CELL INTERNATIONAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 8137492188 |
| prepacytecustomerserive@cryo-cell.com |
| Width | 7.04 Centimeter |
| Width | 7.04 Centimeter |
| Width | 7.04 Centimeter |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00861880000326 [Primary] |
| OAO | Cord Blood Processing System And Storage Container |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-10-21 |
| 00861880000326 | The PrepaCyte CB (Cord Blood) Processing System is intended for use in cell processing laborator |
| 00861880000319 | Indications for Use: The PrepaCyte-CB (Cord Blood) Processing System is intended for use in cell |
| 00861880000302 | Indications for Use: The PrepaCyte-CB (Cord Blood) Processing System is intended for use in cell |