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) (9) Generator, oxygen, portable (CAW) (1)

Premarket Exempt

No Yes

Clear

BiPAP - 00606959001060 Catalog Number : CN757HS

Device Description : BiPAP Auto Bilevel System with Humidifier and SD Card, China

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

EverFlo - 00606959001077 Catalog Number : 1020010

Device Description : EverFlo with Oxygen Percentage Indicator, 230V, AU

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

EASYLIFE - 00606959001299 Catalog Number : 1050021

Device Description : EasyLife Mask with Headgear, Small, International

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

EASYLIFE - 00606959001305 Catalog Number : 1050022

Device Description : EasyLife Mask with Headgear, Medium, International

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

EASYLIFE - 00606959001312 Catalog Number : 1050023

Device Description : EasyLife Mask w/Headgear, Medium Wide, International

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

EASYLIFE - 00606959001329 Catalog Number : 1050024

Device Description : Large EasyLife Mask with Headgear, China

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

OPTILIFE - 00606959001442 Catalog Number : 1036836

Device Description : OPTILIFE MASK ASSEMBLY wHeadgear, NO CUSHIONS-INTL

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

OPTILIFE - 00606959001459 Catalog Number : 1036837

Device Description : OPTILIFE MASK ASSEMBLY without HGR, NO CUSHIONS-INTL

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

ComfortGel Blue - 00606959001572 Catalog Number : 1070064

Device Description : ComfortGel Blue Nasal Mask with Headgear, Large, International

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

ComfortGel Blue - 00606959001589 Catalog Number : 1070065

Device Description : ComfortGel Blue Nasal Mask with Headgear, Medium, International

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

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