Respironics, Inc.

Address:6501 Living Place,Pittsburgh,PA,15206,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

VENTILATOR, NON-CONTINUOUS (RESPIRATOR) (BZD) (7) Ventilator, continuous, minimal ventilatory support, facility use (MNT) (3) Ventilator, continuous, non-life-supporting (MNS) (2)

Premarket Exempt

No Yes

Clear

Amara View - 00606959061385 Catalog Number : 1090670RTL

Device Description : Amara View Mask wHGR, FitPack-RTL

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Dream Wisp - 00606959061460 Catalog Number : 1137916RTL

Device Description : Fitpk DreamWisp Nsl, MED Con WHGR -RTL

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

A Series Heated Huminifier - 00606959061668 Catalog Number : 1147249

Device Description : A Series, Sys One, Heated Hum, CN

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : MNT, MNS

Prescription Use : Yes

Device Count : 1

A Series Humidifier - 00606959061958 Catalog Number : 1147250

Device Description : Hum, A Series, Sys One, Flow Gen, CN

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : MNS, MNT

Prescription Use : Yes

Device Count : 1

BiPAP - 00606959062061 Catalog Number : SPX3100S19

Device Description : BiPAP A40 Pro, Sapio Belife 40 Pro

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : MNT

Prescription Use : Yes

Device Count : 1

DreamWear - 00606959062108 Catalog Number : 1146410AP

Device Description : Small, DreamWear Silicone Pillows, Small Frame with Headgear, Asian Pacific

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DreamWear - 00606959062115 Catalog Number : 1146415AP

Device Description : Medium, DreamWear Silicone Pillows, Medium Frame with Headgear, Asian Pacific

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DreamWear - 00606959062122 Catalog Number : 1146450AP

Device Description : Large, DreamWear Silicone Pillows, Large Frame with Headgear, Asian Pacific

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DreamWear - 00606959062139 Catalog Number : 1146469AP

Device Description : DreamWear Silicone Pillows, FitPack, Asian Pacific

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DreamWear - 00606959062146 Catalog Number : 1146469CE

Device Description : DreamWear Silicone Pillows, FitPack, Central Europe

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

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