Primary Device ID | 00814112020234 |
NIH Device Record Key | e8671a6c-7712-4741-a905-32a05ad419ce |
Commercial Distribution Discontinuation | 2015-11-13 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | TandemHeart- TRIS |
Version Model Number | 5140-6221TRIS |
Company DUNS | 948683941 |
Company Name | CARDIACASSIST, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | true |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
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 |
00814112020586 - LifeSPARC | 2023-03-06 Controller Battery |
00814112020692 - TandemLife LifeSPARC | 2022-08-05 LifeSPARC Blood Pump, TandemLung Oxygenator, 17 Fr Arterial Cannula, 24 Fr Venous Cannula, and accessories |
00814112020708 - TandemLife LifeSPARC | 2022-08-05 LifeSPARC Blood Pump, TandemLung Oxygenator, 15 Fr Arterial Cannula, 24 Fr Venous Cannnula and accessories |
00814112020906 - LifeSPARC | 2022-05-18 IV Pole Clamp for blood pump controller |
00814112020609 - LifeSPARC | 2020-06-08 LifeSPARC Priming Tray Kit: LIfeSPARC Blood Pump with TandemLung Oxygenator |
00814112020685 - TandemLife LifeSPARC | 2020-06-08 LifeSPARC Blood Pump, TandemLung Oxygenator and accessories |
00814112020753 - TandemLung LifeSPARC | 2020-06-08 LifeSPARC Blood Pump, TandemLung Oxygenator, 29 Fr ProtekDuo Veno-Venous cannula and accessories |
00814112020760 - TandemLung LifeSPARC | 2020-06-08 LifeSPARC Blood Pump, TandemLung Oxygenator, 31 Fr ProtekDuo Veno-Venous cannula and accessories |