| Primary Device ID | 10816203020472 |
| NIH Device Record Key | 001eff96-4714-4826-b955-6122d3d5560b |
| Commercial Distribution Discontinuation | 2024-12-11 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | CryoBag |
| Version Model Number | CB10K2 |
| Company DUNS | 625272232 |
| Company Name | ORIGEN BIOMEDICAL, 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 | false |
| 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 | 512-474-7278 |
| regulatory@origen.com | |
| Phone | 512-474-7278 |
| regulatory@origen.com | |
| Phone | 512-474-7278 |
| regulatory@origen.com | |
| Phone | 512-474-7278 |
| regulatory@origen.com | |
| Phone | 512-474-7278 |
| regulatory@origen.com | |
| Phone | 512-474-7278 |
| regulatory@origen.com | |
| Phone | 512-474-7278 |
| regulatory@origen.com | |
| Phone | 512-474-7278 |
| regulatory@origen.com | |
| Phone | 512-474-7278 |
| regulatory@origen.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10816203020472 [Primary] |
| LPZ | Container, Frozen Donor Tissue Storage |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2024-12-12 |
| Device Publish Date | 2016-09-23 |
| 10816203020700 | Cryobag, 14 x 28, Kapton/FEP |
| 10816203020694 | Cryobag, 19 x 36, Kapton/FEP |
| 10816203020687 | Cryobag, 14 x 20, Kapton/FEP |
| 10816203020656 | Cryobag, 09x15, Kapton/FEP |
| 10816203020663 | Cryobag, 10x16, Kapton/FEP |
| 10816203020472 | CryoBag with ports, 10ml Kapton and FEP bag |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CRYOBAG 78026674 not registered Dead/Abandoned |
OriGen Biomedical 2000-09-19 |