CARDIACASSIST, INC.

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Filters

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

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (DWF) (8) Accessory Equipment, Cardiopulmonary Bypass (KRI) (7) Dilator, Vessel, For Percutaneous Catheterization (DRE) (6) Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type (KFM) (6) Oxygenator, Cardiopulmonary Bypass (DTZ) (5)

Premarket Exempt

No Yes

Clear

ProtekDuo - 00814112020456 Catalog Number :

Device Description : Four 25 cm Dilators (14 Fr, 18 Fr, 22 Fr, and 26 Fr)

Device Class : 2

Duns Number: 948683941

Premarket Exempt : No

Product Code : DRE

Prescription Use : No

Device Count : 1

ProtekSolo - 00814112020463 Catalog Number :

Device Description : Three 25 cm Dilators (14 Fr, 18 Fr, and 22 Fr)

Device Class : 2

Duns Number: 948683941

Premarket Exempt : No

Product Code : DRE

Prescription Use : No

Device Count : 1

TandemLife - 00814112020470 Catalog Number :

Device Description : TandemLife blood pump kit with oxygenator and accessories

Device Class : 1

Duns Number: 948683941

Premarket Exempt : No

Product Code : DTZ, DWF, KRI, KFM

Prescription Use : Yes

Device Count : 1

TandemLife - 00814112020494 Catalog Number :

Device Description : TandemLife Priming Tray Kit: TandemHeart Blood Pump with TandemLung Oxygenator

Device Class : 1

Duns Number: 948683941

Premarket Exempt : No

Product Code : DWF, KRI, KFM, DTZ

Prescription Use : Yes

Device Count : 1

TandemLife - 00814112020500 Catalog Number :

Device Description : TandemLife Priming Tray Accessory Kit

Device Class : 1

Duns Number: 948683941

Premarket Exempt : Yes

Product Code : DWF, KRI

Prescription Use : Yes

Device Count : 1

TandemLife - 00814112020517 Catalog Number :

Device Description : TandemHeart blood pump,TandemLung Oxygenator,17 Fr Arterial 24 Fr Venous Cannula TandemHeart blood pump,TandemLung Oxygenator,17 Fr Arterial 24 Fr Venous Cannula, and accessories

Device Class : 1

Duns Number: 948683941

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

TandemLife - 00814112020524 Catalog Number :

Device Description : TandemHeart blood pump,TandemLung Oxygenator,15 Fr Arterial,24 Fr Venous Cannnul TandemHeart blood pump,TandemLung Oxygenator,15 Fr Arterial,24 Fr Venous Cannnula and accessories

Device Class : 1

Duns Number: 948683941

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

ProtekDuo - 00814112020531 Catalog Number :

Device Description : 31 Fr x 36 cm Dual Lumen VV Cannula Set

Device Class : 2

Duns Number: 948683941

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

ProtekDuo - 00814112020548 Catalog Number :

Device Description : TandemHeart Blood Pump Kit with 31 Fr Mini Veno-Venous Cannula

Device Class : 1

Duns Number: 948683941

Premarket Exempt : No

Product Code : DRE, KRI, KFM, DWF

Prescription Use : Yes

Device Count : 1

ProtekDuo - 00814112020555 Catalog Number :

Device Description : TandemHeart Blood Pump Kit with 31 Fr Mini V-V cannula, TandemLung Oxygentor

Device Class : 1

Duns Number: 948683941

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

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