| Primary Device ID | 38033178112742 |
| NIH Device Record Key | 994f09fb-da80-4045-8faa-6e3209149c0c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EOS PMP |
| Version Model Number | Oxygenator |
| Company DUNS | 442126587 |
| Company Name | SORIN GROUP ITALIA SRL |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 | 08033178112741 [Primary] |
| GS1 | 38033178112742 [Package] Contains: 08033178112741 Package: BOX [2 Units] In Commercial Distribution |
| DTZ | OXYGENATOR, CARDIOPULMONARY BYPASS |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-01-22 |
| Device Publish Date | 2015-06-26 |
| 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 |