Primary Device ID | 20816203023432 |
NIH Device Record Key | 8fbf45a4-4ab7-407e-9afe-fd76cd0a67d7 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Accessories |
Version Model Number | 40-PF-2M |
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 | 10816203023435 [Primary] |
GS1 | 20816203023432 [Package] Contains: 10816203023435 Package: pouch [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 | 2 |
Public Version Date | 2021-02-19 |
Device Publish Date | 2018-08-14 |
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 |