Primary Device ID | 20816203023197 |
NIH Device Record Key | c040fc66-4a1d-4361-ad48-9c7362582efd |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Accessory Set |
Version Model Number | 45-F-9M |
Catalog Number | 45-F-9M |
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 | 512-474-7578 |
regulatory@origen.com | |
Phone | 512-474-7578 |
regulatory@origen.com | |
Phone | 512-474-7578 |
regulatory@origen.com | |
Phone | 512-474-7578 |
regulatory@origen.com | |
Phone | 512-474-7578 |
regulatory@origen.com | |
Phone | 512-474-7578 |
regulatory@origen.com | |
Phone | 512-474-7578 |
regulatory@origen.com | |
Phone | 512-474-7578 |
regulatory@origen.com | |
Phone | 512-474-7578 |
regulatory@origen.com | |
Phone | 512-474-7578 |
regulatory@origen.com | |
Phone | 512-474-7578 |
regulatory@origen.com | |
Phone | 512-474-7578 |
regulatory@origen.com | |
Phone | 512-474-7578 |
regulatory@origen.com | |
Phone | 512-474-7578 |
regulatory@origen.com | |
Phone | 512-474-7578 |
regulatory@origen.com | |
Phone | 512-474-7578 |
regulatory@origen.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10816203023190 [Primary] |
GS1 | 20816203023197 [Package] Contains: 10816203023190 Package: case [10 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 | 2017-03-06 |
20816203023265 | Two spikes to nine male luers with 140cm SCD tubing and pinch clamps |
20816203023197 | One female luer to 9 male luers, 45cm PVC tubing, with pinch clamps |