Maquet Cardiopulmonary AG

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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) Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass (DTL) (1) CATHETER, PERCUTANEOUS (DQY) (1) PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE (KFM) (1)

Premarket Exempt

No Yes

Clear

NA - 04037691122267 Catalog Number : 70102.2680

Device Description : Arterial Cannula, wire reinforced, straight tip, stylet, with Luer lock connector

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

NA - 04037691122274 Catalog Number : 70102.2681

Device Description : Arterial Cannula, wire reinforced, straight tip, stylet, with Luer lock connector

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

NA - 04037691122281 Catalog Number : 70102.5697

Device Description : Arterial Cannula, wire reinforced, straight tip, stylet, with Luer lock connector

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

NA - 04037691122298 Catalog Number : 70102.5698

Device Description : Arterial Cannula, wire reinforced, straight tip, stylet, with Luer lock connector

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

ROTAFLOW - 04037691123554 Catalog Number : 70101.8066

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : KFM

Prescription Use : Yes

Device Count : 1

NA - 04037691123820 Catalog Number : 70101.4232

Device Description : Venous Catheter, two-stage, SLIM, complete reinforcement, elliptic proximal body Venous Catheter, two-stage, SLIM, complete reinforcement, elliptic proximal body, Lighthouse tip, with connector

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DTL, DWF

Prescription Use : Yes

Device Count : 1

NA - 04037691129778 Catalog Number : 70100.2229

Device Description : Arterial Cannula, wire reinforced, straight tip with ring

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

NA - 04037691131122 Catalog Number : 70102.2683

Device Description : Arterial Cannula, wire reinforced, straight tip, stylet, with Luer lock connector

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

NA - 04037691144184 Catalog Number : 70100.4972

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

NA - 04037691152219 Catalog Number : 70102.3434

Device Description : Venous Catheter, wire reinforced with Full Lumen tip, 90° bent

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

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