EOPA 3D®

GUDID 20763000135700

CANNULA 78222 EOPA 3D 22FR VNTED 10P 17L

MEDTRONIC, INC.

Cardiopulmonary bypass cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial

• Primary Device ID: 20763000135700
• NIH Device Record Key: 2b63ed74-4652-4682-98ab-fe094cf4b137
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EOPA 3D®
• Version Model Number: 78222
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 10
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Catheter Gauge: 22 French
• Catheter Gauge: 22 French
• Catheter Gauge: 22 French
• Catheter Gauge: 22 French
• Catheter Gauge: 22 French
• Catheter Gauge: 22 French
• Catheter Gauge: 22 French
• Catheter Gauge: 22 French
• Catheter Gauge: 22 French
• Catheter Gauge: 22 French
• Catheter Gauge: 22 French
• Catheter Gauge: 22 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000135706 [Unit of Use]
GS1	20763000135700 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150422

FDA Product Code

• DWF: Catheter, cannula and tubing, vascular, cardiopulmonary bypass

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-07
• Device Publish Date: 2019-04-22

On-Brand Devices [EOPA 3D®]

• 00613994888693: CANN CB78322 EOPA 3D 22FR O-VNT 17L
• 00613994888679: CANN CB78222 EOPA 3D 22FR VNTED 17L
• 00613994888662: CANN CB78220 EOPA 3D 20FR VNTED 17L
• 20643169486250: CANNULA 78222 EOPA 3D 22FR VNTED 10P 17L
• 20643169486243: CANNULA 78220 EOPA 3D 20FR VNTED 10P 17L
• 20613994845287: CANNULA 78322 EOPA 3D 22FR O-VNT 10P 17L
• 20613994845270: CANNULA 78320 EOPA 3D 20FR O-VNT 10P 17L
• 20613994845263: CANNULA 78222 EOPA 3D 22FR VNTED 10P 17L
• 20613994845256: CANNULA 78220 EOPA 3D 20FR VNTED 10P 17L
• 20763000135700: CANNULA 78222 EOPA 3D 22FR VNTED 10P 17L
• 20763000135694: CANNULA 78220 EOPA 3D 20FR VNTED 10P 17L
• 20763000135526: CANNULA 78322 EOPA 3D 22FR O-VNT 10P 17L
• 20763000135502: CANNULA 78320 EOPA 3D 20FR O-VNT 10P 17L