Primary Device ID | 20816203022183 |
NIH Device Record Key | ba812b4a-f6aa-413a-a2c2-1e69778bed25 |
Commercial Distribution Discontinuation | 2024-12-12 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | Tube Set |
Version Model Number | 30-T-SPF |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10816203022186 [Primary] |
GS1 | 20816203022183 [Package] Contains: 10816203022186 Package: Case [12 Units] Discontinued: 2024-12-12 Not 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 | 2024-12-13 |
Device Publish Date | 2016-09-23 |
20816203021100 - CryoStore Freezing Bag | 2024-12-16 CryoStore 30 EVA Multi-Chamber Freezing Bag, 30ml, "M9" Tube Set |
20816203022824 - Accessories | 2024-12-16 One 60ml syringe with one 0.22um filter and one 5um filter Single aseptically pouched |
20816203023449 - Accessories | 2024-12-16 6 mL syringe with 5 mL of air on a female luer with 15cm sealed SCD tubing |
10816203023657 - PermaLife™ Cell Culture Bag | 2024-12-16 PermaLife Cell Culture Bag, 30ml, "K" Set |
10816203023664 - PermaLife™ Cell Culture Bag | 2024-12-16 PermaLife Cell Culture Bag, 70ml, "K" Set |
10816203023671 - PermaLife™ Cell Culture Bag | 2024-12-16 PermaLife Cell Culture Bag, 120ml, "K" Set |
10816203023688 - PermaLife™ Cell Culture Bag | 2024-12-16 PermaLife Cell Culture Bag, 500ml, "K" Set |
10816203023695 - PermaLife™ Cell Culture Bag | 2024-12-16 PermaLife Cell Culture Bag, 750ml, "K" Set |