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

ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE (CCK) (5) Anesthesia breathing circuit kit (adult & pediatric) (OFP) (4) Ventilator, continuous, facility use (CBK) (1)

Premarket Exempt

No Yes

Clear

Vital Signs™ - 10190752111691 Catalog Number : 587040600

Device Description : Patient Hytrel Tube, Adult, Reusable, 750 mm/ 30 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™ - 10190752111707 Catalog Number : 587040700

Device Description : Patient Hytrel Tube, Adult, Reusable, 1500 mm/ 59 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™ - 10190752111714 Catalog Number : 587040800

Device Description : Patient Hytrel Tube, Adult, Reusable, 1000 mm/ 39 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™ - 10190752111721 Catalog Number : 587040900

Device Description : Patient Hytrel Tube, Adult, Reusable, 1200 mm/ 47 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™ - 10190752113763 Catalog Number : 5640

Device Description : Vital Signs™ Gas Sampling Interface

Device Class : 2

Duns Number: 080456871

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

LTV - 10190752113770 Catalog Number : 21102-001

Device Description : LTV 1100 Ventilator, English

Device Class : 2

Duns Number: 080456871

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

AirLife™ - 10190752113923 Catalog Number : 2802F-10

Device Description : AirLife™ Nasal ETCO2 Cannula, Pediatric with 7 foot O2 tube and 7 foot CO2 tube AirLife™ Nasal ETCO2 Cannula, Pediatric with 7 foot O2 tube and 7 foot CO2 tube with female luer connector and 22 mm (I.D.) x 6 mm (O.D.) adapter

Device Class : 2

Duns Number: 080456871

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

AirLife™ - 10190752113930 Catalog Number : 2802M-10

Device Description : AirLife™ Nasal ETCO2 Cannula, Pediatric with 7 foot O2 tube and 7 foot CO2 tube AirLife™ Nasal ETCO2 Cannula, Pediatric with 7 foot O2 tube and 7 foot CO2 tube with male luer connector and 22 mm (I.D.) x 6 mm (O.D.) adaptor

Device Class : 2

Duns Number: 080456871

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

AirLife™ - 10190752113947 Catalog Number : 2811F-10

Device Description : AirLife™ Nasal ETCO2 Cannula, Adult with 7 foot O2 tube and 2 inch CO2 tube with AirLife™ Nasal ETCO2 Cannula, Adult with 7 foot O2 tube and 2 inch CO2 tube with female luer connector and 22 mm (I.D.) x 6 mm (O.D.) adaptor

Device Class : 2

Duns Number: 080456871

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

AirLife™ - 10190752113954 Catalog Number : 2811M-10

Device Description : AirLife™ Nasal ETCO2 Cannula, Adult with 7 foot O2 tube and 2 inch CO2 tube with AirLife™ Nasal ETCO2 Cannula, Adult with 7 foot O2 tube and 2 inch CO2 tube with male luer connector and 22 mm (I.D.) x 6 mm (O.D.) adaptor

Device Class : 2

Duns Number: 080456871

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

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