VALFLUX GROUP, LLC

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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

INJECTOR AND SYRINGE, ANGIOGRAPHIC (DXT) (5) Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass (DTL) (4) Syringe, balloon inflation (MAV) (1)

Premarket Exempt

No Yes

Clear

MANIFOLD - 00850004162019 Catalog Number : VGAM0201

Device Description : VGAM0201 MANIFOLD

Device Class : 2

Duns Number: 050193715

Premarket Exempt : Yes

Product Code : DTL

Prescription Use : Yes

Device Count : 1

MANIFOLD - 00850004162026 Catalog Number : VGAM0301

Device Description : VGAM0301 MANIFOLD

Device Class : 2

Duns Number: 050193715

Premarket Exempt : Yes

Product Code : DTL

Prescription Use : Yes

Device Count : 1

MANIFOLD - 00850004162033 Catalog Number : VGAM0401

Device Description : VGAM0401 MANIFOLD

Device Class : 2

Duns Number: 050193715

Premarket Exempt : Yes

Product Code : DTL

Prescription Use : Yes

Device Count : 1

INFLATION DEVICE - 00850004162040 Catalog Number : VGAI25C

Device Description : VGAI25C INFLATION DEVICE

Device Class : 2

Duns Number: 050193715

Premarket Exempt : No

Product Code : MAV

Prescription Use : Yes

Device Count : 1

Y CONNECTOR KIT - 00850004162057 Catalog Number : VGYCK113F

Device Description : VGYCK113F Y CONNECTOR KIT

Device Class : 2

Duns Number: 050193715

Premarket Exempt : No

Product Code : DTL

Prescription Use : Yes

Device Count : 1

HIGH PRESSURE TUBING - 00850004162064 Catalog Number : VGPMT0501

Device Description : VGPMT0501 HIGH PRESSURE TUBING (30cm)

Device Class : 2

Duns Number: 050193715

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

HIGH PRESSURE TUBING - 00850004162071 Catalog Number : VGPMT0502

Device Description : VGPMT0502 HIGH PRESSURE TUBING (60cm)

Device Class : 2

Duns Number: 050193715

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

HIGH PRESSURE TUBING - 00850004162088 Catalog Number : VGPMT0503

Device Description : VGPMT0503 HIGH PRESSURE TUBING (90cm)

Device Class : 2

Duns Number: 050193715

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

HIGH PRESSURE TUBING - 00850004162095 Catalog Number : VGPMT0504

Device Description : VGPMT0504 HIGH PRESSURE TUBING (120cm)

Device Class : 2

Duns Number: 050193715

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

HIGH PRESSURE TUBING - 00850004162101 Catalog Number : VGPMT0505

Device Description : VGPMT0505 HIGH PRESSURE TUBING (150cm)

Device Class : 2

Duns Number: 050193715

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

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