EOPA 3D®
GUDID 00613994888693
CANN CB78322 EOPA 3D 22FR O-VNT 17L
MEDTRONIC, INC.
Cardiopulmonary bypass cannula, arterial 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 | 00613994888693 |
| NIH Device Record Key | 922beb8d-0d5f-45a1-ad51-780ee049c3b7 |
| Commercial Distribution Discontinuation | 2018-10-05 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | EOPA 3D® |
| Version Model Number | CB78322 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, 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 | true |
| 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 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| 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 |
| Catheter Gauge | 22 French |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994888693 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K061254
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 | 4 |
| Public Version Date | 2018-12-13 |
| Device Publish Date | 2016-09-03 |
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 |
Trademark Results [EOPA 3D]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EOPA 3D 78736279 3308984 Live/Registered |
Medtronic, Inc. 2005-10-19 |
 EOPA 3D 75606531 not registered Dead/Abandoned |
Medtronic, Inc. 1998-12-16 |
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