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, CONTINUOUS, FACILITY USE (CBK) (7) VENTILATOR, NON-CONTINUOUS (RESPIRATOR) (BZD) (5)

Premarket Exempt

No Yes

Clear

Contour Deluxe - 00606959000742 Catalog Number : 1119000

Device Description : Contour Deluxe Mask and Headgear, Single Patient Use, Medium/Large, International

Device Class :

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

PerforMax - 00606959000759 Catalog Number : 1049037

Device Description : Performax Mask with Entrainment Elbow and Standard Elbow, Multi Patient Use, Lea

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD, CBK

Prescription Use : Yes

Device Count : 1

PerforMax - 00606959000766 Catalog Number : 1049038

Device Description : Performax Mask with Entrainment Elbow Leak 2 & Standard Elbow, Multi-Patient Use

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD, CBK

Prescription Use : Yes

Device Count : 1

PERFORMATRAK - 00606959000773 Catalog Number : 1023025

Device Description : PerformaTrak Mask with Standard Elbow, Small, Reusable Pack, International

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

PERFORMATRAK - 00606959000780 Catalog Number : 1023026

Device Description : PerformaTrak Mask with Standard Elbow, Medium, Reusable Pack, International

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

PERFORMATRAK - 00606959000797 Catalog Number : 1023027

Device Description : PerformaTrak Mask with Standard Elbow, Large, Reusable Pack, International

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

PerforMax - 00606959000858 Catalog Number : 1054966

Device Description : PerforMax Mask, Single Patient Use, with Entrainment Elbow, INTL, Small

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

PerforMax - 00606959000865 Catalog Number : 1054997

Device Description : PerforMax Mask, Single Patient Use, with Entrainment Elbow, International, Large

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

PerforMax - 00606959000872 Catalog Number : 1054998

Device Description : PerforMax Mask with Standard Elbow, Single Patient Use, International, Small

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

PerforMax - 00606959000889 Catalog Number : 1054999

Device Description : PerforMax Mask with Standard Elbow, Single Patient Use, International, Large

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

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