CARDIACASSIST, INC.

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Accessory Equipment, Cardiopulmonary Bypass (KRI) (10) Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type (KFM) (10) Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (DWF) (9) Oxygenator, Cardiopulmonary Bypass (DTZ) (6) Dilator, Vessel, For Percutaneous Catheterization (DRE) (5)

Premarket Exempt

Yes No

Clear

TandemLife LifeSPARC - 00814112020685 Catalog Number :

Device Description : LifeSPARC Blood Pump, TandemLung Oxygenator and accessories

Device Class : 1

Duns Number: 948683941

Premarket Exempt : No

Product Code : KRI, KFM, DTZ

Prescription Use : Yes

Device Count : 1

TandemLife LifeSPARC - 00814112020692 Catalog Number :

Device Description : LifeSPARC Blood Pump, TandemLung Oxygenator, 17 Fr Arterial Cannula, 24 Fr Venou LifeSPARC Blood Pump, TandemLung Oxygenator, 17 Fr Arterial Cannula, 24 Fr Venous Cannula, and accessories

Device Class : 1

Duns Number: 948683941

Premarket Exempt : No

Product Code : KRI, KFM, DTZ, DRE, DWF

Prescription Use : Yes

Device Count : 1

TandemLife LifeSPARC - 00814112020708 Catalog Number :

Device Description : LifeSPARC Blood Pump, TandemLung Oxygenator, 15 Fr Arterial Cannula, 24 Fr Venou LifeSPARC Blood Pump, TandemLung Oxygenator, 15 Fr Arterial Cannula, 24 Fr Venous Cannnula and accessories

Device Class : 1

Duns Number: 948683941

Premarket Exempt : No

Product Code : KRI, KFM, DTZ, DRE, DWF

Prescription Use : Yes

Device Count : 1

LifeSPARC - 00814112020715 Catalog Number :

Device Description : LifeSPARC Blood Pump Kit with 62cm Transseptal Cannula and 17Fr Arterial Cannula

Device Class : 1

Duns Number: 948683941

Premarket Exempt : No

Product Code : KRI, KFM, DWF

Prescription Use : Yes

Device Count : 1

LifeSPARC - 00814112020722 Catalog Number :

Device Description : LifeSPARC Blood Pump Kit with 62cm Transseptal Cannula and 15Fr Arterial Cannula

Device Class : 1

Duns Number: 948683941

Premarket Exempt : No

Product Code : KRI, KFM, DWF

Prescription Use : Yes

Device Count : 1

LifeSPARC - 00814112020739 Catalog Number :

Device Description : LifeSPARC Blood Pump Kit with 72cm Transseptal Cannula and 17Fr Arterial Cannula

Device Class : 1

Duns Number: 948683941

Premarket Exempt : No

Product Code : KRI, KFM, DWF

Prescription Use : Yes

Device Count : 1

LifeSPARC - 00814112020746 Catalog Number :

Device Description : LifeSPARC Blood Pump Kit with 72cm Transseptal Cannula and 15Fr Arterial Cannula

Device Class : 1

Duns Number: 948683941

Premarket Exempt : No

Product Code : KRI, KFM, DWF

Prescription Use : Yes

Device Count : 1

TandemLung LifeSPARC - 00814112020753 Catalog Number :

Device Description : LifeSPARC Blood Pump, TandemLung Oxygenator, 29 Fr ProtekDuo Veno-Venous cannula LifeSPARC Blood Pump, TandemLung Oxygenator, 29 Fr ProtekDuo Veno-Venous cannula and accessories

Device Class : 1

Duns Number: 948683941

Premarket Exempt : No

Product Code : KRI, KFM, DTZ, DRE, DWF

Prescription Use : Yes

Device Count : 1

TandemLung LifeSPARC - 00814112020760 Catalog Number :

Device Description : LifeSPARC Blood Pump, TandemLung Oxygenator, 31 Fr ProtekDuo Veno-Venous cannula LifeSPARC Blood Pump, TandemLung Oxygenator, 31 Fr ProtekDuo Veno-Venous cannula and accessories

Device Class : 1

Duns Number: 948683941

Premarket Exempt : No

Product Code : KRI, KFM, DTZ, DRE, DWF

Prescription Use : Yes

Device Count : 1

TandemLung LifeSPARC - 00814112020777 Catalog Number :

Device Description : LifeSPARC Blood Pump, TandemLung Oxygenator, 31 Fr ProtekDuo Veno-Venous Rapid D LifeSPARC Blood Pump, TandemLung Oxygenator, 31 Fr ProtekDuo Veno-Venous Rapid Deployment cannula and accessories

Device Class : 1

Duns Number: 948683941

Premarket Exempt : No

Product Code : KRI, KFM, DTZ, DRE, DWF

Prescription Use : Yes

Device Count : 1

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