Catheter w/ Blunt Introducer

GUDID 10816203022124

Mobile extracorporeal gas exchange system catheter kit

Primary Device ID	10816203022124
NIH Device Record Key	ddcea963-2d81-4da3-9e40-dafc349b32bf
Commercial Distribution Discontinuation	2024-12-12
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	Catheter w/ Blunt Introducer
Version Model Number	VV28F
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

Device Issuing Agency	Device ID
GS1	10816203022124 [Primary]

DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Steralize Prior To Use	false
Device Is Sterile	true

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