Respironics, Inc.

Address:920 SW Emkay Drive, Suite 100,Bend,OR,97702,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) (5) Continuous, ventilator, home use (NOU) (3) Ventilator, continuous, facility use (CBK) (3) Medical device data system (OUG) (1) Ventilator, continuous, minimal ventilatory support, facility use (MNT) (1)

Premarket Exempt

No Yes

Clear

Trilogy Evo - 00606959061019 Catalog Number : FX2100X15B

Device Description : Trilogy Evo, O2, International

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : NOU, CBK

Prescription Use : Yes

Device Count : 1

Trilogy Evo - 00606959061026 Catalog Number : FX2110X15B

Device Description : Trilogy Evo, International

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : NOU, CBK

Prescription Use : Yes

Device Count : 1

Trilogy EV300 - 00606959061033 Catalog Number : FX2200X15B

Device Description : Trilogy EV300, Intl

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : NOU, CBK

Prescription Use : Yes

Device Count : 1

DreamStation Humidifier, INTL - 00606959061040 Catalog Number : INXH

Device Description : DreamStation Humidifier, International

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DreamWear Full - 00606959061071 Catalog Number : 1133372UA

Device Description : Large, DreamWear Full, Small and Medium Frame, Ukraine

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DreamWear Full - 00606959061088 Catalog Number : 1133373UA

Device Description : Medium Wide, DreamWear Full, Small and Medium Frame, Ukraine

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DreamStation - 00606959061118 Catalog Number : BLX500H15MQ

Device Description : DreamStation Auto CPAP with Humidifier, Mediq

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DreamStation - 00606959061132 Catalog Number : 1147056

Device Description : DreamStation SpO2 Connection Module

Device Class : 1

Duns Number: 080728314

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : Yes

Device Count : 1

BiPAP - 00606959061231 Catalog Number : 1146885

Device Description : Transcutaneous CO2 Connection Cable

Device Class : 2

Duns Number: 080728314

Premarket Exempt : Yes

Product Code : MNT

Prescription Use : Yes

Device Count : 1

DreamStation - 00606959061316 Catalog Number : JPX501S16

Device Description : DreamStation Auto CPAP, 12mm, Japan

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

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