Catheter w/ Blunt Introducer

GUDID 10816203022148

ECMO Reinforced Dual Lumen Cannula, 32F

ORIGEN BIOMEDICAL, INC.

Mobile extracorporeal gas exchange system catheter kit
Primary Device ID10816203022148
NIH Device Record Key9433e4bb-e8ef-405b-b6d1-779ea42c116b
Commercial Distribution Discontinuation2024-12-12
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCatheter w/ Blunt Introducer
Version Model NumberVV32F
Company DUNS625272232
Company NameORIGEN BIOMEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110816203022148 [Primary]

FDA Product Code

DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2024-12-13
Device Publish Date2016-09-23

On-Brand Devices [Catheter w/ Blunt Introducer]

10816203022148ECMO Reinforced Dual Lumen Cannula, 32F
10816203022124ECMO Reinforced Dual Lumen Cannula, 28F
10816203022100ECMO Reinforced Dual Lumen Cannula, 23F
10816203022094ECMO Reinforced Dual Lumen Cannula, 19F
10816203022070ECMO Reinforced Dual Lumen Cannula, 16F
10816203022056ECMO Reinforced Dual Lumen Cannula, 13F

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