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

Attachment, breathing, positive end expiratory pressure (BYE) (9) ANALYZER, GAS, OXYGEN, GASEOUS-PHASE (CCL) (1)

Premarket Exempt

No Yes

Clear

WhisperPak, M572 V10 T956 C142 C955 Case 10 - 00884838082540 Catalog Number : 1021532

Device Class : 2

Duns Number: 093608594

Premarket Exempt : No

Product Code : BYE

Prescription Use : Yes

Device Count : 1

WhisperPak, PerformaTrak, MED - 00884838082557 Catalog Number : 1024665

Device Class : 2

Duns Number: 093608594

Premarket Exempt : No

Product Code : BYE

Prescription Use : Yes

Device Count : 1

WhisperPak, M691 V10 T2m C500, Case 10 - 00884838082564 Catalog Number : 1028526

Device Class : 2

Duns Number: 093608594

Premarket Exempt : No

Product Code : BYE

Prescription Use : Yes

Device Count : 1

WhisperPak, M572 V10 T987 C142 C955, 10 - 00884838082571 Catalog Number : 1052885

Device Class : 2

Duns Number: 093608594

Premarket Exempt : No

Product Code : BYE

Prescription Use : Yes

Device Count : 1

Criterion OxiCheck - 00884838083189 Catalog Number : 8-100661-00

Device Class : 2

Duns Number: 093608594

Premarket Exempt : No

Product Code : CCL

Prescription Use : Yes

Device Count : 1

Whisperflow CPAP Valve - 00884838083219 Catalog Number : 8-208503-00

Device Class : 2

Duns Number: 093608594

Premarket Exempt : No

Product Code : BYE

Prescription Use : Yes

Device Count : 1

Whisperflow CPAP Valve - 00884838083226 Catalog Number : 8-208505-00

Device Class : 2

Duns Number: 093608594

Premarket Exempt : No

Product Code : BYE

Prescription Use : Yes

Device Count : 1

Whisperflow CPAP Valve - 00884838083233 Catalog Number : 8-208507-00

Device Class : 2

Duns Number: 093608594

Premarket Exempt : No

Product Code : BYE

Prescription Use : Yes

Device Count : 1

Whisperflow CPAP Valve - 00884838083240 Catalog Number : 8-208510-00

Device Class : 2

Duns Number: 093608594

Premarket Exempt : No

Product Code : BYE

Prescription Use : Yes

Device Count : 1

Whisperpak CPAP Valve - 00884838083257 Catalog Number : 8-208512-00

Device Class : 2

Duns Number: 093608594

Premarket Exempt : No

Product Code : BYE

Prescription Use : Yes

Device Count : 1

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