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) TUBING, PRESSURE AND ACCESSORIES (BYX) (2) STRAP, HEAD, GAS MASK (BTK) (1)

Premarket Exempt

No Yes

Clear

ComfortGel Blue - 00606959001596 Catalog Number : 1070066

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

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

ComfortGel Blue - 00606959001602 Catalog Number : 1070067

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

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

FITLIFE - 00606959001794 Catalog Number : 1060803

Device Description : FitLife Mask with Headgear, Small, International

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

FITLIFE - 00606959001800 Catalog Number : 1060804

Device Description : FitLife Mask with Headgear, Large, International

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

PREMIUM CHIN STRAP - 00606959002142 Catalog Number : 1012911

Device Description : Premium Chin Strap

Device Class : 1

Duns Number: 080728314

Premarket Exempt : Yes

Product Code : BTK

Prescription Use : Yes

Device Count : 1

Circuit Tubing - 00606959002166 Catalog Number : 622038

Device Description : Reusable Flexible Tubing, Grey

Device Class : 1

Duns Number: 080728314

Premarket Exempt : Yes

Product Code : BYX

Prescription Use : Yes

Device Count : 1

Circuit Tubing - 00606959002173 Catalog Number : 1032907

Device Description : Performance Tubing 6ft (1.83m)

Device Class : 1

Duns Number: 080728314

Premarket Exempt : Yes

Product Code : BYX

Prescription Use : Yes

Device Count : 1

System One - 00606959002210 Catalog Number : 1056210

Device Description : System One REMstar Heated Humidifier, International

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Pressure Valve - 00606959002562 Catalog Number : 302418

Device Description : Pressure Valve - Single

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Total Face Mask - 00606959002586 Catalog Number : 302433

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

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