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, FACILITY USE (CBK) (3)

Premarket Exempt

No Yes

Clear

PERFORMATRAK - 00606959000636 Catalog Number : 1012623

Device Description : PerformaTrak Mask with Headgear, Disposable, Small, USA

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

PERFORMATRAK - 00606959000643 Catalog Number : 1012624

Device Description : PerformaTrak Mask with Headgear, Disposable, Medium, USA

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

PERFORMATRAK - 00606959000650 Catalog Number : 1012572

Device Description : PerformaTrak Mask with Headgear, Disposable, Large, USA

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

PERFORMATRAK - 00606959000667 Catalog Number : 1022980

Device Description : PerformaTrak Mask, Small, Reusable Pack, International

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

PERFORMATRAK - 00606959000674 Catalog Number : 1023022

Device Description : PerformaTrak Mask, Medium, Reusable Pack, International

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

PERFORMATRAK - 00606959000681 Catalog Number : 1023023

Device Description : PerformaTrak Mask, Large, Reusable Pack, International

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

PERFORMATRAK - 00606959000698 Catalog Number : 1012636

Device Description : PerformaTrak SE Mask w/Headgear, Disposable, Small, USA

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

PERFORMATRAK - 00606959000704 Catalog Number : 1012637

Device Description : PerformaTrak Standard Elbow Mask w/Headgear, Disposable, Medium, USA

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

PERFORMATRAK - 00606959000711 Catalog Number : 1012638

Device Description : PerformaTrak Standard Elbow Mask w/Headgear, Disposable, Large, USA

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

Contour Deluxe - 00606959000735 Catalog Number : 1118999

Device Description : Contour Deluxe Mask and Headgear, Single Patient Use, Small, International

Device Class :

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

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