EOPA 3D™
GUDID 00643169696457
CANNULA CB78322 EOPA 3D 22FR
MEDTRONIC, INC.
Cardiopulmonary bypass cannula, arterial| Primary Device ID | 00643169696457 |
| NIH Device Record Key | 1b5b4607-bb06-406f-a5ae-8023ebdc11b7 |
| Commercial Distribution Status | 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
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 |
| 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 |
| 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 |
| 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 |
| 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 | 00643169696457 [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 | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-03-04 |
On-Brand Devices [EOPA 3D™]
| 00643169696457 | CANNULA CB78322 EOPA 3D 22FR |
| 00643169696440 | CANNULA CB78222 EOPA 3D 22FR |
| 00643169561076 | CANN CB78222 EOPA 3D 22FR VNTED 17L |
| 00763000238490 | CANN CB78322 EOPA 3D 22FR |
| 00763000238483 | CANN CB78222 EOPA 3D 22FR |
| 00763000192976 | CANNULA CB78322 EOPA 3D 22FR |
| 00763000192969 | CANN CB78222 EOPA 3D 22FR VNTED 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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.