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) (7) ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE (CCK) (3)

Premarket Exempt

No Yes

Clear

Capnostat 5 Mainstream CO2 Sensor - 00884838013667 Catalog Number : 1015928

Device Class : 2

Duns Number: 093608594

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

Capnostat CO2 Sensor - 00884838013674 Catalog Number : 7167-00

Device Class : 2

Duns Number: 093608594

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

Respironics LoFlo Sidestream CO2 Module - 00884838013681 Catalog Number : 1022054

Device Class : 2

Duns Number: 093608594

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

Respironics - 00884838013773 Catalog Number : 3468ADU-00

Device Description : LoFlo CO2 Sampling Cannula ADULT NASAL

Device Class : 1

Duns Number: 093608594

Premarket Exempt : Yes

Product Code : CAT

Prescription Use : Yes

Device Count : 1

Respironics - 00884838013780 Catalog Number : 3468PED-00

Device Description : LoFlo CO2 Sampling Cannula PEDIATRIC NASAL

Device Class : 1

Duns Number: 093608594

Premarket Exempt : Yes

Product Code : CAT

Prescription Use : Yes

Device Count : 1

Respironics - 00884838013797 Catalog Number : 3468INF-00

Device Description : LoFlo CO2 Sampling Cannula INFANT/NEONATAL NASAL

Device Class : 1

Duns Number: 093608594

Premarket Exempt : Yes

Product Code : CAT

Prescription Use : Yes

Device Count : 1

Respironics - 00884838013803 Catalog Number : 3469ADU-00

Device Description : LoFlo CO2 Sampling O2 Delivery Cannula ADULT NASAL

Device Class : 1

Duns Number: 093608594

Premarket Exempt : Yes

Product Code : CAT

Prescription Use : Yes

Device Count : 1

Respironics - 00884838013810 Catalog Number : 3469PED-00

Device Description : LoFlo CO2 Sampling O2 Delivery Cannula PEDIATRIC NASAL

Device Class : 1

Duns Number: 093608594

Premarket Exempt : Yes

Product Code : CAT

Prescription Use : Yes

Device Count : 1

Respironics - 00884838013827 Catalog Number : 3469INF-00

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

Device Class : 1

Duns Number: 093608594

Premarket Exempt : Yes

Product Code : CAT

Prescription Use : Yes

Device Count : 1

Respironics - 00884838013834 Catalog Number : 3470ADU-00

Device Description : LoFlo CO2 Sampling Cannula ADULT ORAL/NASAL

Device Class : 1

Duns Number: 093608594

Premarket Exempt : Yes

Product Code : CAT

Prescription Use : Yes

Device Count : 1

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