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) (4)

Premarket Exempt

No Yes

Clear

DreamStation 2 - 00606959063082 Catalog Number : VAX520H21C

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DreamStation 2 - 00606959063099 Catalog Number : VAX520T21C

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DreamStation 2 - 00606959063228 Catalog Number : DSX410H11C

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

DreamStation - 00606959417540 Catalog Number : 0

Device Description : Micro-Flexible Heated 12mm Tube

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

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