| Primary Device ID | 00814112020708 |
| NIH Device Record Key | f5e6f421-9372-407f-8529-6f2a353cb91c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TandemLife LifeSPARC |
| Version Model Number | 5840-2415 |
| Company DUNS | 948683941 |
| Company Name | CARDIACASSIST, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814112020708 [Primary] |
| KRI | Accessory Equipment, Cardiopulmonary Bypass |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-08-05 |
| Device Publish Date | 2020-06-01 |
| 00814112020685 | LifeSPARC Blood Pump, TandemLung Oxygenator and accessories |
| 00814112020708 | LifeSPARC Blood Pump, TandemLung Oxygenator, 15 Fr Arterial Cannula, 24 Fr Venous Cannnula and a |
| 00814112020692 | LifeSPARC Blood Pump, TandemLung Oxygenator, 17 Fr Arterial Cannula, 24 Fr Venous Cannula, and a |