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

Anesthesia breathing circuit kit (adult & pediatric) (OFP) (3) Circuit, breathing (w connector, adaptor, y piece) (CAI) (3) TUBING, PRESSURE AND ACCESSORIES (BYX) (2) BAG, RESERVOIR (BTC) (1) CONNECTOR, AIRWAY (EXTENSION) (BZA) (1)

Premarket Exempt

No Yes

Clear

Vital Signs™ - 10190752108882 Catalog Number : M1036379

Device Description : Patient Circuit Tube on the Roll, Adult, Disposable, 30 m/1200 in

Device Class : 1

Duns Number: 080456871

Premarket Exempt : Yes

Product Code : BYX

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10190752108899 Catalog Number : M1036380

Device Description : Patient Circuit Tube on the Roll, Pediatric, Disposable, 30 m/1200 in

Device Class : 1

Duns Number: 080456871

Premarket Exempt : Yes

Product Code : BYX

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10190752108912 Catalog Number : M1036383

Device Description : Elbow, Disposable

Device Class : 1

Duns Number: 080456871

Premarket Exempt : Yes

Product Code : BZA

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10190752108950 Catalog Number : M1036388

Device Description : Breathing Bag, Disposable, 3 L

Device Class : 1

Duns Number: 080456871

Premarket Exempt : Yes

Product Code : BTC

Prescription Use : Yes

Device Count : 1

Vital Signs® - 10190752109131 Catalog Number : M1093632

Device Description : ABS Start Up Tubing Set, Adult, Disposable,1.8 m/72 in

Device Class : 1

Duns Number: 080456871

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : Yes

Device Count : 1

Vital Signs® - 10190752109148 Catalog Number : M1093633

Device Description : ABS Start Up Tubing Set, Adult, Disposable, 1.8 m/72 in

Device Class : 1

Duns Number: 080456871

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : Yes

Device Count : 1

Vital Signs® - 10190752109155 Catalog Number : M1093636

Device Description : ABS Start Up Tubing Set, Adult, Disposable, 1.8 m/72 in

Device Class : 1

Duns Number: 080456871

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10190752111653 Catalog Number : 8004515

Device Description : Patient Hytrel Tube, Adult, Reusable, 900 mm/ 35 in, connectors 22/22 mm

Device Class : 1

Duns Number: 080456871

Premarket Exempt : Yes

Product Code : OFP

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10190752111660 Catalog Number : 427010700

Device Description : Patient Hytrel Tube, Pediatric, Reusable, 1500 mm/59 in, connectors 22/15 mm

Device Class : 1

Duns Number: 080456871

Premarket Exempt : Yes

Product Code : OFP

Prescription Use : Yes

Device Count : 1

Vital Signs™ - 10190752111684 Catalog Number : 587040500

Device Description : Patient Hytrel Tube, Adult, Reusable, 450 mm/ 18 in, connectors 22/22 mm

Device Class : 1

Duns Number: 080456871

Premarket Exempt : Yes

Product Code : OFP

Prescription Use : Yes

Device Count : 1

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