Primary Device ID | 20816203024019 |
NIH Device Record Key | 70161aeb-af8d-438f-be6c-2ece31483738 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | TissueVault™ Cell & Tissue Freezing Bag |
Version Model Number | TV0909 |
Catalog Number | TV0909 |
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 | 10816203024012 [Primary] |
GS1 | 20816203024019 [Package] Contains: 10816203024012 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 |