| Primary Device ID | 08033178101622 |
| NIH Device Record Key | 1fa42d55-fddb-4027-ad70-63e0ece95278 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vanguard, CSC 14 and HSC |
| Version Model Number | Holder |
| Company DUNS | 442126587 |
| Company Name | SORIN GROUP ITALIA SRL |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08033178101622 [Primary] |
| KRI | ACCESSORY EQUIPMENT, 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 | 2023-11-01 |
| Device Publish Date | 2023-10-24 |
| 38033178004009 - Aortic-Root Cannula | 2025-04-17 |
| 38033178004016 - Aortic-Root Cannula | 2025-04-17 |
| 38033178004023 - Aortic-Root Cannula | 2025-04-17 |
| 38033178004030 - Aortic-Root Cannula | 2025-04-17 |
| 38033178004047 - Aortic-Root Cannula | 2025-04-17 |
| 38033178004054 - Aortic-Root Cannula | 2025-04-17 |
| 38033178114562 - MICRO | 2025-03-12 |
| 38033178114579 - MICRO | 2025-03-12 |