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

CANNULA, NASAL, OXYGEN (CAT) (9) CONNECTOR, AIRWAY (EXTENSION) (BZA) (1)

Premarket Exempt

No Yes

Clear

Respironics - 00884838013940 Catalog Number : 3468PEH-00

Device Description : LoFlo CO2 Sampling Cannula with Dehumidification Tubing PEDIATRIC NASAL

Device Class : 1

Duns Number: 093608594

Premarket Exempt : Yes

Product Code : CAT

Prescription Use : Yes

Device Count : 1

Respironics - 00884838013957 Catalog Number : 3468INH-00

Device Description : LoFlo CO2 Sampling Cannula with Dehumidification Tubing INFANT/NEONATAL NASAL

Device Class : 1

Duns Number: 093608594

Premarket Exempt : Yes

Product Code : CAT

Prescription Use : Yes

Device Count : 1

Respironics - 00884838013964 Catalog Number : 3469ADH-00

Device Description : LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing ADULT NASAL

Device Class : 1

Duns Number: 093608594

Premarket Exempt : Yes

Product Code : CAT

Prescription Use : Yes

Device Count : 1

Respironics - 00884838013971 Catalog Number : 3469PEH-00

Device Description : LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing PEDIATRIC NASAL

Device Class : 1

Duns Number: 093608594

Premarket Exempt : Yes

Product Code : CAT

Prescription Use : Yes

Device Count : 1

Respironics - 00884838013988 Catalog Number : 3469INH-00

Device Description : LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing INFANT/NEONATAL NASAL

Device Class : 1

Duns Number: 093608594

Premarket Exempt : Yes

Product Code : CAT

Prescription Use : Yes

Device Count : 1

Respironics - 00884838013995 Catalog Number : 3470ADH-00

Device Description : LoFlo CO2 Sampling Cannula with Dehumidification Tubing ADULT ORAL/NASAL

Device Class : 1

Duns Number: 093608594

Premarket Exempt : Yes

Product Code : CAT

Prescription Use : Yes

Device Count : 1

Respironics - 00884838014008 Catalog Number : 3470PEH-00

Device Description : LoFlo CO2 Sampling Cannula with Dehumidification Tubing PEDIATRIC ORAL/NASAL

Device Class : 1

Duns Number: 093608594

Premarket Exempt : Yes

Product Code : CAT

Prescription Use : Yes

Device Count : 1

Respironics - 00884838014015 Catalog Number : 3471ADH-00

Device Description : LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing ADULT ORAL/NASAL

Device Class : 1

Duns Number: 093608594

Premarket Exempt : Yes

Product Code : CAT

Prescription Use : Yes

Device Count : 1

Respironics - 00884838014022 Catalog Number : 3471PEH-00

Device Description : LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing PEDIATRIC ORAL/NASAL

Device Class : 1

Duns Number: 093608594

Premarket Exempt : Yes

Product Code : CAT

Prescription Use : Yes

Device Count : 1

Respironics - 00884838014039 Catalog Number : 6063-00

Device Description : Pediatric/Adult Airway Adapter

Device Class : 1

Duns Number: 093608594

Premarket Exempt : Yes

Product Code : BZA

Prescription Use : Yes

Device Count : 1

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