Respironics Novametrix, LLC

Address:2271 Cosmos Ct.,Carlsbad,CA,92011,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

TRANSDUCER, GAS FLOW (BXP) (6) CONNECTOR, AIRWAY (EXTENSION) (BZA) (4)

Premarket Exempt

No Yes

Clear

Respironics - 00884838014046 Catalog Number : 6312-00

Device Description : Neonatal/Pediatric Airway Adapter

Device Class : 1

Duns Number: 093608594

Premarket Exempt : Yes

Product Code : BZA

Prescription Use : Yes

Device Count : 1

Respironics - 00884838014053 Catalog Number : 6421-00

Device Description : Pediatric/Adult Airway Adapter with Mouthpiece

Device Class : 1

Duns Number: 093608594

Premarket Exempt : Yes

Product Code : BZA

Prescription Use : Yes

Device Count : 1

Respironics - 00884838014060 Catalog Number : 7007-01

Device Description : Pediatric/Adult Airway Adapter

Device Class : 1

Duns Number: 093608594

Premarket Exempt : Yes

Product Code : BZA

Prescription Use : Yes

Device Count : 1

Respironics - 00884838014077 Catalog Number : 7053-01

Device Description : Neonatal Airway Adapter

Device Class : 1

Duns Number: 093608594

Premarket Exempt : Yes

Product Code : BZA

Prescription Use : Yes

Device Count : 1

Respironics - 00884838014114 Catalog Number : 6719-00

Device Description : Pediatric / Adult Combined CO2/Flow Sensor Series 3

Device Class : 1

Duns Number: 093608594

Premarket Exempt : Yes

Product Code : BXP

Prescription Use : Yes

Device Count : 1

Respironics - 00884838014121 Catalog Number : 6716-00

Device Description : Pediatric Combined CO2/Flow Sensor Series 3

Device Class : 1

Duns Number: 093608594

Premarket Exempt : Yes

Product Code : BXP

Prescription Use : Yes

Device Count : 1

Respironics - 00884838014138 Catalog Number : 6720-00

Device Description : Neonatal Combined CO2/Flow Sensor Series 3

Device Class : 1

Duns Number: 093608594

Premarket Exempt : Yes

Product Code : BXP

Prescription Use : Yes

Device Count : 1

Respironics - 00884838014145 Catalog Number : 6717-00

Device Description : Pediatric/Adult Flow Sensor Series 3

Device Class : 1

Duns Number: 093608594

Premarket Exempt : Yes

Product Code : BXP

Prescription Use : Yes

Device Count : 1

Respironics - 00884838014152 Catalog Number : 6718-00

Device Description : Neonatal Flow Sensor Series 3

Device Class : 1

Duns Number: 093608594

Premarket Exempt : Yes

Product Code : BXP

Prescription Use : Yes

Device Count : 1

Respironics - 00884838014350 Catalog Number : 9765-00

Device Description : CO2/Flow Sensor Neonatal

Device Class : 1

Duns Number: 093608594

Premarket Exempt : Yes

Product Code : BXP

Prescription Use : Yes

Device Count : 1

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