Primary Device ID | 10816203022148 |
NIH Device Record Key | 9433e4bb-e8ef-405b-b6d1-779ea42c116b |
Commercial Distribution Discontinuation | 2024-12-12 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | Catheter w/ Blunt Introducer |
Version Model Number | VV32F |
Company DUNS | 625272232 |
Company Name | ORIGEN BIOMEDICAL, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
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 | 10816203022148 [Primary] |
DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
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 |
10816203022148 | ECMO Reinforced Dual Lumen Cannula, 32F |
10816203022124 | ECMO Reinforced Dual Lumen Cannula, 28F |
10816203022100 | ECMO Reinforced Dual Lumen Cannula, 23F |
10816203022094 | ECMO Reinforced Dual Lumen Cannula, 19F |
10816203022070 | ECMO Reinforced Dual Lumen Cannula, 16F |
10816203022056 | ECMO Reinforced Dual Lumen Cannula, 13F |