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) (6) CONNECTOR, AIRWAY (EXTENSION) (BZA) (4)

Premarket Exempt

No Yes

Clear

Respironics - 00884838013841 Catalog Number : 3470PED-00

Device Description : LoFlo CO2 Sampling Cannula PEDIATRIC ORAL/NASAL

Device Class : 1

Duns Number: 093608594

Premarket Exempt : Yes

Product Code : CAT

Prescription Use : Yes

Device Count : 1

Respironics - 00884838013858 Catalog Number : 3471ADU-00

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

Device Class : 1

Duns Number: 093608594

Premarket Exempt : Yes

Product Code : CAT

Prescription Use : Yes

Device Count : 1

Respironics - 00884838013865 Catalog Number : 3471PED-00

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

Device Class : 1

Duns Number: 093608594

Premarket Exempt : Yes

Product Code : CAT

Prescription Use : Yes

Device Count : 1

Respironics - 00884838013872 Catalog Number : 3472ADU-00

Device Description : LoFlo Airway Adapter Kit ADULT/PEDIATRIC

Device Class : 1

Duns Number: 093608594

Premarket Exempt : Yes

Product Code : BZA

Prescription Use : Yes

Device Count : 1

Respironics - 00884838013889 Catalog Number : 3472INF-00

Device Description : LoFlo Airway Adapter Kit INFANT/NEONATAL

Device Class : 1

Duns Number: 093608594

Premarket Exempt : Yes

Product Code : BZA

Prescription Use : Yes

Device Count : 1

Respironics - 00884838013896 Catalog Number : 3473ADU-00

Device Description : LoFlo Airway Adapter Kit w/ Dehumidification Tubing Adult/Pediatric

Device Class : 1

Duns Number: 093608594

Premarket Exempt : Yes

Product Code : BZA

Prescription Use : Yes

Device Count : 1

Respironics - 00884838013902 Catalog Number : 3473INF-00

Device Description : LoFlo Airway Adapter Kit w/Dehumidification Tubing INFANT/NEONATAL

Device Class : 1

Duns Number: 093608594

Premarket Exempt : Yes

Product Code : BZA

Prescription Use : Yes

Device Count : 1

Respironics - 00884838013919 Catalog Number : 3474-00

Device Description : LoFlo SAMPLING LINE KIT

Device Class : 1

Duns Number: 093608594

Premarket Exempt : Yes

Product Code : CAT

Prescription Use : Yes

Device Count : 1

Respironics - 00884838013926 Catalog Number : 3475-00

Device Description : LoFlo SAMPLING LINE KIT w/Dehumidification Tubing

Device Class : 1

Duns Number: 093608594

Premarket Exempt : Yes

Product Code : CAT

Prescription Use : Yes

Device Count : 1

Respironics - 00884838013933 Catalog Number : 3468ADH-00

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

Device Class : 1

Duns Number: 093608594

Premarket Exempt : Yes

Product Code : CAT

Prescription Use : Yes

Device Count : 1

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