Maquet Cardiopulmonary AG

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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

CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS (DWF) (8) Defoamer, cardiopulmonary bypass (DTP) (1) Filter, blood, cardiopulmonary bypass, arterial line (DTM) (1)

Premarket Exempt

No Yes

Clear

VBT Venous Bubble Trap - 04037691075051 Catalog Number : 70103.0884

Device Description : Venous Bubble Trap, BIOLINE Coating (BEQ), and sterile. The Venous Bubble Trap V Venous Bubble Trap, BIOLINE Coating (BEQ), and sterile. The Venous Bubble Trap VBT 160 is designed to remove gross air in the venous line before it is entering the arterial pump and the following components of the extra corporeal circuit (ECC). The VBT has been especially developed as an additional safety feature for minimized systems, e.g. MECC, where venous reservoirs are missing. The VBT is using different physical principals for air removal.

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DTP

Prescription Use : Yes

Device Count : 1

NA - 04037691078137 Catalog Number : 70100.4642

Device Description : Venous Catheter, wire reinforced, Bullet tip, straight

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

NA - 04037691078144 Catalog Number : 70100.4589

Device Description : Venous Catheter, wire reinforced, Bullet tip, straight

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

QUART - 04037691078977 Catalog Number : 70100.4263

Device Description : Quart Arterial Filter, no coating, HBF 140#Arterieller Filter Quart

Device Class :

Duns Number: 316153865

Premarket Exempt : No

Product Code : DTM

Prescription Use : Yes

Device Count : 1

NA - 04037691083230 Catalog Number : 70100.4980

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

NA - 04037691084855 Catalog Number : 70100.4696

Device Description : Venous Catheter, wire reinforced, Lighthouse tip, 90° bent

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

NA - 04037691084879 Catalog Number : 70100.4711

Device Description : Venous Catheter, wire reinforced, Lighthouse tip, 90° bent

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

NA - 04037691084886 Catalog Number : 70100.4679

Device Description : Venous Catheter, wire reinforced, Lighthouse tip, 90° bent

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

NA - 04037691084893 Catalog Number : 70100.4664

Device Description : Venous Catheter, wire reinforced, Lighthouse tip, 90° bent

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

NA - 04037691084909 Catalog Number : 70100.4652

Device Description : Venous Catheter, wire reinforced, Lighthouse tip, 90° bent

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

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