Primary Device ID | 20816203022824 |
NIH Device Record Key | c5e5fbda-b557-4240-a0be-57467157fff8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Accessories |
Version Model Number | 80HAS |
Catalog Number | 80HAS |
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 | true |
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 |
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 | 10816203022827 [Primary] |
GS1 | 20816203022824 [Package] Contains: 10816203022827 Package: Carton [10 Units] In Commercial Distribution |
KJG | Tube, Tissue Culture |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-12-16 |
Device Publish Date | 2024-12-06 |
20816203023432 | Two male luers to one spike port and one female luer with 20cm SCD tubing with pinch clamps. |
20816203023449 | 6 mL syringe with 5 mL of air on a female luer with 15cm sealed SCD tubing |
20816203022824 | One 60ml syringe with one 0.22um filter and one 5um filter Single aseptically pouched |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ACCESSORIES 97145991 not registered Live/Pending |
taha s qattum 2021-11-29 |
ACCESSORIES 79090741 not registered Dead/Abandoned |
S.Oliver Bernd Freier GmbH & Co. KG 2010-11-24 |