| Primary Device ID | 00886368000469 |
| NIH Device Record Key | 531c82dd-8016-4d06-b017-6977cc792822 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BioArchive System |
| Version Model Number | 8-4000-0 |
| Catalog Number | 8-4000-0 |
| Company DUNS | 175719335 |
| Company Name | CESCA THERAPEUTICS INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00886368000469 [Primary] |
| KSE | Refrigerator, Freezer, Blood Storage |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-04-05 |
| 10886368000312 - MXP Processing Bagset | 2019-04-09 Cell separation processing and collection bag set. |
| 00886368000353 - MXP Device | 2019-04-09 Cell separation processing device |
| 00886368000384 - MXP Docking Station | 2019-04-09 Cell separation processing, docking station |
| 00886368000391 - MXP Start Up Kit | 2019-04-09 Startup kit for the MXP System |
| 10886368000305 - AXP Disposable Processing Bagset | 2018-07-06 Cord blood processing system and storage container |
| 20886368000326 - QC Bagset | 2018-07-06 Utilized for quality control testing of the AXP Device. |
| 00886368000346 - AXP Device | 2018-07-06 Cord blood processing system |
| 00886368000360 - AXP Docking Station | 2018-07-06 Cord blood processing system docking station |