| Primary Device ID | 20816203024156 |
| NIH Device Record Key | d5e7523f-b2e2-4a20-aa96-c6e7e312f5c5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TissueVault™ Cell & Tissue Freezing Bag |
| Version Model Number | TV0918 |
| Catalog Number | TV0918 |
| Company DUNS | 625272232 |
| Company Name | ORIGEN BIOMEDICAL, 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 | 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 | +1-512-474-7278 |
| regulatory@origenbio.com | |
| Phone | +1-512-474-7278 |
| regulatory@origenbio.com | |
| Phone | +1-512-474-7278 |
| regulatory@origenbio.com | |
| Phone | +1-512-474-7278 |
| regulatory@origenbio.com | |
| Phone | +1-512-474-7278 |
| regulatory@origenbio.com | |
| Phone | +1-512-474-7278 |
| regulatory@origenbio.com | |
| Phone | +1-512-474-7278 |
| regulatory@origenbio.com | |
| Phone | +1-512-474-7278 |
| regulatory@origenbio.com | |
| Phone | +1-512-474-7278 |
| regulatory@origenbio.com | |
| Phone | +1-512-474-7278 |
| regulatory@origenbio.com | |
| Phone | +1-512-474-7278 |
| regulatory@origenbio.com | |
| Phone | +1-512-474-7278 |
| regulatory@origenbio.com | |
| Phone | +1-512-474-7278 |
| regulatory@origenbio.com | |
| Phone | +1-512-474-7278 |
| regulatory@origenbio.com |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not re-use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not resterilize |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not re-use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not resterilize |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not re-use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not resterilize |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not re-use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not resterilize |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not re-use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not resterilize |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not re-use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not resterilize |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not re-use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not resterilize |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not re-use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not resterilize |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not re-use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not resterilize |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not re-use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not resterilize |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not re-use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not resterilize |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not re-use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not resterilize |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not re-use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not resterilize |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not re-use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not resterilize |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10816203024159 [Primary] |
| GS1 | 20816203024156 [Package] Contains: 10816203024159 Package: Carton [100 Units] In Commercial Distribution |
| FMH | Container, Specimen, Sterile |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-26 |
| Device Publish Date | 2025-06-18 |
| 20816203024156 | TissueVault, Cell and Tissue Freezing 9x18cm bag |
| 20816203024019 | TissueVault, Cell and Tissue Freezing 9x9cm bag |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() TISSUEVAULT 98492743 not registered Live/Pending |
OriGen Biomedical, Inc. 2024-04-10 |