Vero Biotech Inc.

Vero Biotech 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

SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS) (BZO) (8) APPARATUS, NITRIC OXIDE DELIVERY (MRN) (2)

Premarket Exempt

No

Clear

GENOSYL® - 00850000962002 Catalog Number : 601588

Device Description : GENOSYL Delivery System

Device Class : 2

Duns Number: 872672477

Premarket Exempt : No

Product Code : MRN

Prescription Use : Yes

Device Count : 1

GENOSYL® - 00850000962033 Catalog Number : 601690

Device Description : GENOSYL DS Gas Lines

Device Class : 1

Duns Number: 872672477

Premarket Exempt : No

Product Code : BZO

Prescription Use : Yes

Device Count : 1

GENOSYL® - 00850000962040 Catalog Number : 601445-01

Device Description : GENOSYL DS Mixer

Device Class : 2

Duns Number: 872672477

Premarket Exempt : No

Product Code : MRN

Prescription Use : Yes

Device Count : 1

GENOSYL® - 00850000962057 Catalog Number : 601485

Device Description : GENOSYL DS Manual Ventilation Bag NO Adapter

Device Class : 1

Duns Number: 872672477

Premarket Exempt : No

Product Code : BZO

Prescription Use : Yes

Device Count : 1

GENOSYL® - 00850000962071 Catalog Number : 601966-01

Device Description : GENOSYL DS Vapotherm Accessory Kit

Device Class : 1

Duns Number: 872672477

Premarket Exempt : No

Product Code : BZO

Prescription Use : Yes

Device Count : 1

GENOSYL® - 00850000962088 Catalog Number : 601758-02

Device Description : 25 mm, 0.22µm Disc Filter

Device Class : 1

Duns Number: 872672477

Premarket Exempt : No

Product Code : BZO

Prescription Use : Yes

Device Count : 1

GENOSYL® - 00850000962095 Catalog Number : 601954-01

Device Description : GENOSYL DS Bunnell Adapter

Device Class : 1

Duns Number: 872672477

Premarket Exempt : No

Product Code : BZO

Prescription Use : Yes

Device Count : 1

GENOSYL® - 00850000962118 Catalog Number : 602069-01

Device Description : GENOSYL DS Vapotherm Accessory Kit

Device Class : 1

Duns Number: 872672477

Premarket Exempt : No

Product Code : BZO

Prescription Use : Yes

Device Count : 1

GENOSYL® - 00850000962125 Catalog Number : 602039-01

Device Description : Gas Inlet Adapter

Device Class : 1

Duns Number: 872672477

Premarket Exempt : No

Product Code : BZO

Prescription Use : Yes

Device Count : 1

GENOSYL® - 00850000962132 Catalog Number : 602069-01

Device Description : GENOSYL DS Vapotherm Acessory Kit

Device Class : 1

Duns Number: 872672477

Premarket Exempt : No

Product Code : BZO

Prescription Use : Yes

Device Count : 1

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