VYAIRE MEDICAL, INC.

Address:510 Technology Dr.,Irvine,CA,92618,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

Cardiopulmonary resuscitation aid kit (OEV) (9) Anesthesia breathing circuit kit (adult & pediatric) (OFP) (1)

Premarket Exempt

No Yes

Clear

AirLife™ - 10190752114098 Catalog Number : 2K8001

Device Description : AirLife™ Adult Manual Resuscitator 40 Inch (1.0 m) Oxygen Reservoir Tubing, without Mask

Device Class : 1

Duns Number: 080456871

Premarket Exempt : Yes

Product Code : OFP

Prescription Use : Yes

Device Count : 1

AirLife™ - 10190752114104 Catalog Number : 2K8004

Device Description : Adult Manual Resuscitator • Oxygen Reservoir Bag, Adult Mask

Device Class : 2

Duns Number: 080456871

Premarket Exempt : Yes

Product Code : OEV

Prescription Use : Yes

Device Count : 1

AirLife™ - 10190752114111 Catalog Number : 2K8004C2

Device Description : Adult Manual Resuscitator •Oxygen Reservoir Bag, Adult Mask, CO2Detector

Device Class : 2

Duns Number: 080456871

Premarket Exempt : Yes

Product Code : OEV

Prescription Use : Yes

Device Count : 1

AirLife™ - 10190752114128 Catalog Number : 2K8004C2M

Device Description : Adult Manual Resuscitator Oxygen Reservoir Bag, Adult Mask, CO2Detector, Pressur Adult Manual Resuscitator Oxygen Reservoir Bag, Adult Mask, CO2Detector, Pressure Manometer

Device Class : 2

Duns Number: 080456871

Premarket Exempt : Yes

Product Code : OEV

Prescription Use : Yes

Device Count : 1

AirLife™ - 10190752114135 Catalog Number : 2K8004F

Device Description : AirLife™ Manual Resuscitator Adult Manual Resuscitator Oxygen Reservoir Bag, Adu AirLife™ Manual Resuscitator Adult Manual Resuscitator Oxygen Reservoir Bag, Adult Mask, Expiratory Filter

Device Class : 2

Duns Number: 080456871

Premarket Exempt : Yes

Product Code : OEV

Prescription Use : Yes

Device Count : 1

AirLife™ - 10190752114142 Catalog Number : 2K8004M

Device Class : 2

Duns Number: 080456871

Premarket Exempt : Yes

Product Code : OEV

Prescription Use : Yes

Device Count : 1

AirLife™ - 10190752114159 Catalog Number : 2K8005

Device Description : AirLife™ Manual Resuscitator Adult Manual Resuscitator 40 inch (1.0 M) Oxygen Re AirLife™ Manual Resuscitator Adult Manual Resuscitator 40 inch (1.0 M) Oxygen Reservoir Tubing, Adult Mask

Device Class : 2

Duns Number: 080456871

Premarket Exempt : Yes

Product Code : OEV

Prescription Use : Yes

Device Count : 1

AirLife™ - 10190752114166 Catalog Number : 2K8005C2

Device Description : Adult Manual Resuscitator, 40”(1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2Detector

Device Class : 2

Duns Number: 080456871

Premarket Exempt : Yes

Product Code : OEV

Prescription Use : Yes

Device Count : 1

AirLife™ - 10190752114173 Catalog Number : 2K8005C2M

Device Description : Adult Manual Resuscitator, 40”(1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2De Adult Manual Resuscitator, 40”(1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2Detector, Pressure Manometer

Device Class : 2

Duns Number: 080456871

Premarket Exempt : Yes

Product Code : OEV

Prescription Use : Yes

Device Count : 1

AirLife™ - 10190752114180 Catalog Number : 2K8005F

Device Description : AirLife™ Manual Resuscitator Adult Manual Resuscitator 40 Inch (1.0 m) Oxygen Re AirLife™ Manual Resuscitator Adult Manual Resuscitator 40 Inch (1.0 m) Oxygen Reservoir Tubing, Adult Mask, Expiratory Filter

Device Class : 2

Duns Number: 080456871

Premarket Exempt : Yes

Product Code : OEV

Prescription Use : Yes

Device Count : 1

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