| Primary Device ID | 00814112020760 |
| NIH Device Record Key | 6212d8c0-1d0c-455e-9bc9-07b1d6b0ebaf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TandemLung LifeSPARC |
| Version Model Number | 5830-3118 |
| 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 | 00814112020760 [Primary] |
| KRI | Accessory Equipment, Cardiopulmonary Bypass |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-06-08 |
| Device Publish Date | 2020-05-29 |
| 00814112020777 | LifeSPARC Blood Pump, TandemLung Oxygenator, 31 Fr ProtekDuo Veno-Venous Rapid Deployment cannul |
| 00814112020760 | LifeSPARC Blood Pump, TandemLung Oxygenator, 31 Fr ProtekDuo Veno-Venous cannula and accessories |
| 00814112020753 | LifeSPARC Blood Pump, TandemLung Oxygenator, 29 Fr ProtekDuo Veno-Venous cannula and accessories |