| Primary Device ID | 00861880000357 |
| NIH Device Record Key | 4d0bfbe6-a10e-470a-a987-8bed70ca1c48 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Newborn Stem Cell Collection Kit Public Kit |
| Version Model Number | Public Kit |
| 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 | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 8137492188 |
| prepacytecustomerservice@cryo-cell.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00861880000357 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-09-26 |
| Device Publish Date | 2019-09-18 |
| 00861880000333 - PrepaCyte-CB 500 | 2022-01-31 The PrepaCyte-CB (Cord Blood) Processing System is intended for use in cell processing laboratories to process and store total n |
| 00861880000340 - Newborn Stem Cell Collection Kit Private kit | 2019-10-15 Newborn Stem Cell Collection Kit for private collection usage |
| 00861880000357 - Newborn Stem Cell Collection Kit Public Kit | 2019-09-26Newborn Stem Cell Collection Kit for Public collection usage. |
| 00861880000357 - Newborn Stem Cell Collection Kit Public Kit | 2019-09-26 Newborn Stem Cell Collection Kit for Public collection usage. |
| 00861880000364 - Newborn Stem Cell Collection Kit International Kit | 2019-09-26 Newborn Stem Cell Collection Kit for International collection usage. |
| 00861880000302 - PrepaCyte-CB | 2018-03-29 Indications for Use: The PrepaCyte-CB (Cord Blood) Processing System is intended for use in cell processing laboratories to proc |
| 00861880000319 - PrepaCyte-CB | 2018-03-29 Indications for Use: The PrepaCyte-CB (Cord Blood) Processing System is intended for use in cell processing laboratories to proc |
| 00861880000326 - PrepaCyte-CB | 2018-03-29 The PrepaCyte CB (Cord Blood) Processing System is intended for use in cell processing laboratories to process and store total n |