Primary Device ID | 20816203023173 |
NIH Device Record Key | 347eac3a-242b-4801-8196-bb5f52147167 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Cell Connect |
Version Model Number | CC35-5MT |
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 | |
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 | 10816203023176 [Primary] |
GS1 | 20816203023173 [Package] Contains: 10816203023176 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 | 2021-02-19 |
Device Publish Date | 2017-01-25 |
10816203020656 - Cryobag | 2024-04-23 Cryobag, 09x15, Kapton/FEP |
10816203022193 - TubeSet Adapter | 2024-04-23 Adapter tube set, 4 bag spikes x 1 Male luer, 40cm |
10816203021462 - TissueVault | 2023-04-11 Cell and Tissue Freezing bag, 19 x 36 cm Poche de Congélation Cellulaire et Tissue Zell- und Gewebe-Gefrierbeutel |
00816203022202 - O-Wrap | 2023-04-11 O-Wrap overwrap 3-layer pouch for freezing, 14x30cm |
00816203022226 - O-Wrap | 2023-04-11 O-Wrap, overwrap pouch for freezing,19x50cm |
00816203022257 - O-Wrap | 2023-04-11 O-Wrap, overwrap pouch for freezing, 24x36cm |
00816203022585 - O-Wrap | 2023-04-11 O-Wrap, overwrap pouch for freezing, 9x9cm. |
00816203022592 - O-Wrap | 2023-04-11 O-Wrap, overwrap pouch for freezing, 9x18cm |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CELL CONNECT 98492746 not registered Live/Pending |
OriGen Biomedical, Inc. 2024-04-10 |