Primary Device ID | 20816203020059 |
NIH Device Record Key | 2e6d338d-8a88-4d87-b721-413ab88c2171 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Cell Connect |
Version Model Number | CC1 |
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 | 10816203020052 [Primary] |
GS1 | 20816203020059 [Package] Contains: 10816203020052 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 |
20816203023173 | 5 male luers with one 20cm SCD Tube and pinch clamp |
20816203020059 | Two spikes to a 3-way stopcock, 60ml syringe and needle-free valve to four male luers with 70cm |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() CELL CONNECT 98492746 not registered Live/Pending |
OriGen Biomedical, Inc. 2024-04-10 |