VYAIRE MEDICAL, INC.

Address:1100 BIRD CENTER DRIVE,Palm Springs,CA,92262,US

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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

CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE) (BYD) (3) CALCULATOR, PULMONARY FUNCTION DATA (BZC) (2) Circuit, breathing (w connector, adaptor, y piece) (CAI) (2) TUBING, PRESSURE AND ACCESSORIES (BYX) (2) CONNECTOR, AIRWAY (EXTENSION) (BZA) (1)

Premarket Exempt

No Yes

Clear

Vyntus - 04250892904726 Catalog Number : V-178604

Device Description : Vyntus ONE

Device Class : 2

Duns Number: 080456871

Premarket Exempt : No

Product Code : BZC

Prescription Use : No

Device Count : 1

Vyntus - 04250892904863 Catalog Number : V-378510

Device Description : Vyntus APS

Device Class : 2

Duns Number: 080456871

Premarket Exempt : No

Product Code : BZC

Prescription Use : Yes

Device Count : 1

AirLife™ - 10190752105867 Catalog Number : 003003

Device Description : Hygroscopic Condenser Humidifier (HCH)

Device Class : 1

Duns Number: 080456871

Premarket Exempt : Yes

Product Code : BYD

Prescription Use : Yes

Device Count : 1

AirLife™ - 10190752105898 Catalog Number : 003009

Device Description : Adult Filtered Hygroscopic Condenser Humidifier (HCH)

Device Class : 1

Duns Number: 080456871

Premarket Exempt : Yes

Product Code : BYD

Prescription Use : Yes

Device Count : 1

AirLife™ - 10190752105928 Catalog Number : 003021

Device Description : Adult Filtered Bypass Heat and Moisture Exchanger (BHME)

Device Class : 1

Duns Number: 080456871

Premarket Exempt : Yes

Product Code : BYD

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10190752108806 Catalog Number : 2066480-026

Device Description : Patient Circuit Kit, Expandable, Adult, Disposable, 3.0 m/120 in

Device Class : 1

Duns Number: 080456871

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10190752108820 Catalog Number : 2066480-028

Device Description : Patient Circuit Kit, Expandable, Adult, Disposable, 3.0 m/120 in

Device Class : 1

Duns Number: 080456871

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10190752108837 Catalog Number : 557033300

Device Description : Flexible Tube, Disposable

Device Class : 1

Duns Number: 080456871

Premarket Exempt : Yes

Product Code : BYX

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10190752108868 Catalog Number : M1036377

Device Description : Double Swivel Elbow, Disposable, with Suction Port

Device Class : 1

Duns Number: 080456871

Premarket Exempt : Yes

Product Code : BZA

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10190752108875 Catalog Number : M1036378

Device Description : Flexible Connector Tube, Disposable, 0.15 m/6 in

Device Class : 1

Duns Number: 080456871

Premarket Exempt : Yes

Product Code : BYX

Prescription Use : Yes

Device Count : 1

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