EOPA CAP®
GUDID 00643169111417
CANN CB77820 EOPA CAP 20FR 10L
MEDTRONIC, INC.
Cardiopulmonary bypass cannula, arterial| Primary Device ID | 00643169111417 |
| NIH Device Record Key | 41f8e760-6a6d-4575-8c82-4e0995f2cbb0 |
| Commercial Distribution Discontinuation | 2018-10-05 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | EOPA CAP® |
| Version Model Number | CB77820 |
| 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 | 20 French |
| Catheter Gauge | 20 French |
| Catheter Gauge | 20 French |
| Catheter Gauge | 20 French |
| Catheter Gauge | 20 French |
| Catheter Gauge | 20 French |
| Catheter Gauge | 20 French |
| Catheter Gauge | 20 French |
| Catheter Gauge | 20 French |
| Catheter Gauge | 20 French |
| Catheter Gauge | 20 French |
| Catheter Gauge | 20 French |
| Catheter Gauge | 20 French |
| Catheter Gauge | 20 French |
| Catheter Gauge | 20 French |
| Catheter Gauge | 20 French |
| Catheter Gauge | 20 French |
| Catheter Gauge | 20 French |
| Catheter Gauge | 20 French |
| Catheter Gauge | 20 French |
| Catheter Gauge | 20 French |
| Catheter Gauge | 20 French |
| Catheter Gauge | 20 French |
| Catheter Gauge | 20 French |
| Catheter Gauge | 20 French |
| Catheter Gauge | 20 French |
| Catheter Gauge | 20 French |
| Catheter Gauge | 20 French |
| Catheter Gauge | 20 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 | 00643169111417 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K031518
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 | 2018-12-19 |
| Device Publish Date | 2016-04-24 |
On-Brand Devices [EOPA CAP®]
| 00643169111424 | CANN CB77818 EOPA CAP 18FR 10L |
| 00643169111417 | CANN CB77820 EOPA CAP 20FR 10L |
Trademark Results [EOPA CAP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EOPA CAP 78030450 2872461 Live/Registered |
MEDTRONIC, INC. 2000-10-13 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.