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) (10)

Premarket Exempt

No Yes

Clear

WhisperPak, M520 V7 H033 T956, Case 10 - 00884838075450 Catalog Number : 1029609

Device Class : 2

Duns Number: 093608594

Premarket Exempt : No

Product Code : BYE

Prescription Use : Yes

Device Count : 1

WhisperPak, M520 V10 H033 T956, Case 10 - 00884838075467 Catalog Number : 1029610

Device Class : 2

Duns Number: 093608594

Premarket Exempt : No

Product Code : BYE

Prescription Use : Yes

Device Count : 1

WhisperPak, M520 V7 H113 T2m, Case 10 - 00884838075474 Catalog Number : 1030346

Device Class : 2

Duns Number: 093608594

Premarket Exempt : No

Product Code : BYE

Prescription Use : Yes

Device Count : 1

WhisperPak 7.5cmH2O CPAP Ribbed, Med, 10 - 00884838075498 Catalog Number : 1044461

Device Class : 2

Duns Number: 093608594

Premarket Exempt : No

Product Code : BYE

Prescription Use : Yes

Device Count : 1

WhisperPak 5.0cmH2O CPAP, Normed Case 10 - 00884838075504 Catalog Number : 1044469

Device Class : 2

Duns Number: 093608594

Premarket Exempt : No

Product Code : BYE

Prescription Use : Yes

Device Count : 1

WhisperPak, M520 V5 H113 T2m, Case 10 - 00884838075542 Catalog Number : 4-100065-00

Device Class : 2

Duns Number: 093608594

Premarket Exempt : No

Product Code : BYE

Prescription Use : Yes

Device Count : 1

WhisperPak, M520 H113 T2m, Case 10 - 00884838075559 Catalog Number : 4-100069-00

Device Class : 2

Duns Number: 093608594

Premarket Exempt : No

Product Code : BYE

Prescription Use : Yes

Device Count : 1

WhisperPak, M520 V10 H113 T2m, Case 10 - 00884838075566 Catalog Number : 4-100112-00

Device Class : 2

Duns Number: 093608594

Premarket Exempt : No

Product Code : BYE

Prescription Use : Yes

Device Count : 1

WhisperPak, Face Mask, Case 10 - 00884838075580 Catalog Number : 8-100337-00

Device Class : 2

Duns Number: 093608594

Premarket Exempt : No

Product Code : BYE

Prescription Use : Yes

Device Count : 1

WhisperPak 5.0cmH2O CPAP Gamida, Case 10 - 00884838075597 Catalog Number : 8-100786-00

Device Class : 2

Duns Number: 093608594

Premarket Exempt : No

Product Code : BYE

Prescription Use : Yes

Device Count : 1

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