Primary Device ID | 20816203020066 |
NIH Device Record Key | 45cab86b-648e-43b2-9cc9-2b4154565145 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Cell Conect |
Version Model Number | CC2 |
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 | 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 | |
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 | 10816203020069 [Primary] |
GS1 | 20816203020066 [Package] Contains: 10816203020069 Package: Case [12 Units] In Commercial Distribution |
KJG | Tube, Tissue Culture |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2025-06-18 |
Device Publish Date | 2016-09-23 |
10816203023800 - Accessories | 2025-06-26 DMSO-Resistant Bag Spike with needle injection port |
20816203023845 - Accessories | 2025-06-26 Needle-free vial spike, DMSO-resistant |
20816203023852 - Accessories | 2025-06-26 3ml syringe on a female luer with 15cm of SCD tubing |
20816203023869 - Accessories | 2025-06-26 6 mL syringe with 5 mL of air on a female luer with 15cm sealed SCD tubing |
20816203023876 - Accessories | 2025-06-26 12ml syringe on a female luer with 15cm sealed SCD tubing |
20816203023883 - Accessories | 2025-06-26 20ml syringe on a female luer with 15cm sealed SCD tubing |
20816203023906 - CryoStore Freezing Bag | 2025-06-26 CryoStore 25 EVA Freezing Bag, 10-25ml, "F" Tube Set, singly packed |
20816203023913 - O-Wrap™ Bag | 2025-06-26 O-Wrap, overwrap pouch for freezing, 9x9cm |