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) (10) Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass (DTL) (7)

Premarket Exempt

No Yes

Clear

NA - 04037691084916 Catalog Number : 70100.4636

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

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

NA - 04037691084923 Catalog Number : 70100.4623

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

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

NA - 04037691084961 Catalog Number : 70100.5670

Device Description : Venous Catheter, two-stage, complete reinforcement, Bullet tip, with connector

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DWF, DTL

Prescription Use : Yes

Device Count : 1

NA - 04037691085005 Catalog Number : 70100.5714

Device Description : Venous Catheter, two-stage, SLIM, complete reinforcement, Bullet tip, with connector

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DWF, DTL

Prescription Use : Yes

Device Count : 1

NA - 04037691085036 Catalog Number : 70100.5720

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

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DTL, DWF

Prescription Use : Yes

Device Count : 1

NA - 04037691085043 Catalog Number : 70100.5716

Device Description : Venous Catheter, two-stage, SLIM, complete reinforcement, Bullet tip, with Lur l Venous Catheter, two-stage, SLIM, complete reinforcement, Bullet tip, with Lur lock connector

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DTL, DWF

Prescription Use : Yes

Device Count : 1

NA - 04037691085098 Catalog Number : 70100.5668

Device Description : Venous Catheter, two-stage, complete reinforcement, Bullet tip, without connector

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DTL, DWF

Prescription Use : Yes

Device Count : 1

NA - 04037691085104 Catalog Number : 70100.5686

Device Description : Venous Catheter, two-stage, complete reinforcement, Bullet tip, without connector

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DWF, DTL

Prescription Use : Yes

Device Count : 1

NA - 04037691085111 Catalog Number : 70100.5713

Device Description : Venous Catheter, two-stage, SLIM, complete reinforcement, Bullet tip, without connector

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DWF, DTL

Prescription Use : Yes

Device Count : 1

NA - 04037691085203 Catalog Number : 70100.4979

Device Class : 2

Duns Number: 316153865

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

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