| Primary Device ID | 00673978861487 |
| NIH Device Record Key | d0833dd7-a82c-46da-a906-f6f0cac45126 |
| Commercial Distribution Discontinuation | 2017-11-30 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | DLP® Aortic Root Cannula with Flow-Guard™ |
| Version Model Number | CB11012 |
| 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 |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00673978861487 [Primary] |
| DWF | CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-04-29 |
| 00673978861494 | CANN CB11014 DLP 14 GA AORTIC ROOT |
| 00673978861487 | CANNULA CB11012 AR FLOWGUARD 12GA 10L |
| 20613994495482 | CANNULA 11014 AR FLOWGUARD 14GA 20PK 17L |
| 20613994495451 | CANNULA 11012 AR FLOWGUARD 12GA 20PK 17L |