| Primary Device ID | 04033817900641 |
| NIH Device Record Key | 739cdd57-81bb-4734-9cf4-507d90ed492c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Level / Bubble |
| Version Model Number | Sensor Module (SCPC) |
| Company DUNS | 343225272 |
| Company Name | LivaNova Deutschland GmbH |
| 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 | 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 | 04033817900641 [Primary] |
| DTQ | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-05-07 |
| Device Publish Date | 2015-10-20 |
| 04033817901693 - Virtual Kit Number | 2024-07-31 |
| 04033817753070 - XVAC | 2024-05-07 |
| 04033817900023 - Venous Line Clamp | 2024-05-07 |
| 04033817900030 - Venous Line Clamp | 2024-05-07 |
| 04033817900047 - Venous Line Clamp | 2024-05-07 |
| 04033817900054 - Venous Line Clamp | 2024-05-07 |
| 04033817900061 - Venous Line Clamp | 2024-05-07 |
| 04033817900078 - Venous Line Clamp | 2024-05-07 |