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) (10)

Premarket Exempt

No Yes

Clear

System One, 50 Series - 00606959000957 Catalog Number : CN157S

Device Description : REMstar CPAP System with SD Card, China

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

REMstar - 00606959000964 Catalog Number : CN257S

Device Description : REMstar Plus CPAP System withC-Flex and SD Card, China

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

REMstar - 00606959000971 Catalog Number : CN457S

Device Description : REMstar Pro CPAP System with C-Flex+ and SD Card, China

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

System One, 50 Series - 00606959000988 Catalog Number : CN557S

Device Description : REMstar Auto A-Flex with SD Card, China

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

BiPAP - 00606959000995 Catalog Number : CN657S

Device Description : BiPAP Pro Bilevel System with Bi-Flex and SD Card, China

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

REMstar - 00606959001015 Catalog Number : CN157HS

Device Description : REMstar CPAP 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

REMstar - 00606959001022 Catalog Number : CN257HS

Device Description : REMstar Plus CPAP System with C-Flex, Humidifier, and SD Card, China

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

REMstar - 00606959001039 Catalog Number : CN457HS

Device Description : REMstar Pro CPAP System withC-Flex+, Humidifier, and SD Card, China

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

REMstar System One 50 Series - 00606959001046 Catalog Number : CN557HS

Device Description : REMstar Auto A-Flex with Humidifier, with SD Card, China

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

BiPAP - 00606959001053 Catalog Number : CN657HS

Device Description : BiPAP Pro Bilevel System with Bi-Flex, Humidifier, and SD Card, China

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

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