| Primary Device ID | 00763000108298 |
| NIH Device Record Key | cd0be735-7d64-4ae9-9933-d69e8ee92196 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 560A |
| 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 | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000108298 [Primary] |
| DWA | Control, pump speed, cardiopulmonary bypass |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-15 |
| Device Publish Date | 2019-03-07 |
| 00763000952693 - NA | 2024-05-23 CUSTOM PACK HY8B11R14 PUMP |
| 00763000899646 - Launcher™ | 2024-05-20 CATHETER LA53DRC LA 5F 100CM 3DRC |
| 00763000899653 - Launcher™ | 2024-05-20 CATHETER LA53DRIGHT LA 5F 100CM 3DRGT |
| 00763000899660 - Launcher™ | 2024-05-20 CATHETER LA5AL10 LA 5F 100CM AL10 |
| 00763000899677 - Launcher™ | 2024-05-20 CATHETER LA5AL1045 LA 5F 100CM A1045 |
| 00763000899684 - Launcher™ | 2024-05-20 CATHETER LA5AL15 LA 5F 100CM AL15 |
| 00763000899691 - Launcher™ | 2024-05-20 CATHETER LA5AL20 LA 5F 100CM AL20 |
| 00763000899707 - Launcher™ | 2024-05-20 CATHETER LA5AL20A LA 5F 110CM AL20 |