CARDIACASSIST, INC.

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) Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type (KFM) (3) Accessory Equipment, Cardiopulmonary Bypass (KRI) (2)

Premarket Exempt

No Yes

Clear

TandemHeart - 00814112020005 Catalog Number :

Device Description : Infusion tubing

Device Class :

Duns Number: 948683941

Premarket Exempt : Yes

Product Code : DWF

Prescription Use : Yes

Device Count : 1

TandemHeart - 00814112020012 Catalog Number :

Device Description : TandemHeart holster, blood pump securement accessory

Device Class : 1

Duns Number: 948683941

Premarket Exempt : Yes

Product Code : KRI

Prescription Use : Yes

Device Count : 1

TandemHeart - 00814112020029 Catalog Number :

Device Description : Infusion tubing (5 pack)

Device Class : 2

Duns Number: 948683941

Premarket Exempt : Yes

Product Code : DWF

Prescription Use : Yes

Device Count : 5

TandemHeart - 00814112020036 Catalog Number :

Device Description : TandemHeart blood pump kit with venous cannula

Device Class : 2

Duns Number: 948683941

Premarket Exempt : No

Product Code : DWF, KFM

Prescription Use : Yes

Device Count : 1

TandemHeart - 00814112020043 Catalog Number :

Device Description : TandemHeart blood pump

Device Class : 2

Duns Number: 948683941

Premarket Exempt : No

Product Code : KFM

Prescription Use : Yes

Device Count : 1

TandemHeart - 00814112020050 Catalog Number :

Device Description : TandemHeart blood pump kit with accessories

Device Class : 1

Duns Number: 948683941

Premarket Exempt : No

Product Code : DWF, KRI, KFM

Prescription Use : Yes

Device Count : 1

TandemHeart - 00814112020067 Catalog Number :

Device Description : 21 Fr x 62 cm venous cannula with dilator and introducer

Device Class : 2

Duns Number: 948683941

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

TandemHeart - 00814112020098 Catalog Number :

Device Description : 21 Fr x 72 cm venous cannula with dilator and introducer

Device Class : 2

Duns Number: 948683941

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

TandemHeart - 00814112020104 Catalog Number : 5130-1717

Device Description : 17 Fr x 17 cm femoral arterial cannula with 12 Fr Introducer

Device Class : 2

Duns Number: 948683941

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

TandemHeart - 00814112020111 Catalog Number : 5130-1715

Device Description : 15 Fr x 17 cm femoral arterial cannula with 10 Fr introducer

Device Class : 2

Duns Number: 948683941

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

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