Respironics, Inc.

Address:920 SW Emkay Drive, Suite 100,Bend,OR,97702,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) (4) Circuit, breathing (w connector, adaptor, y piece) (CAI) (2) Full-montage Standard Electroencephalograph (GWQ) (2) VENTILATORY EFFORT RECORDER (MNR) (1) Ventilator, continuous, minimal ventilatory support, facility use (MNT) (1)

Premarket Exempt

Yes No

Clear

O2 Enrichment Attachment - 00606959002593 Catalog Number : 312010

Device Description : O2 Enrichment Attachment, box of 10

Device Class : 1

Duns Number: 080728314

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : Yes

Device Count : 1

BiPAP - 00606959002616 Catalog Number : 312111

Device Description : BiPAP Disposable Humidifier Tubing, 36 inch, box of 10

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : MNT

Prescription Use : Yes

Device Count : 1

O2 Enrichment Attachment - 00606959002630 Catalog Number : 312710

Device Description : O2 Enrichment Attachment

Device Class : 1

Duns Number: 080728314

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : Yes

Device Count : 1

Performatrak - 00606959003279 Catalog Number : 1041494

Device Description : PERFORMATRAK FULL with CAPSTRAP, SMALL

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Performatrak - 00606959003286 Catalog Number : 1041445

Device Description : PERFORMATRAK FULL with CAPSTRAP, MEDIUM

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

PerformaTrak - 00606959003293 Catalog Number : 1041508

Device Description : PERFORMATRAK FULL FACE MASK WITH CAP STRAP, LARGE

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

ALICE PDx - 00606959003835 Catalog Number : 1043941

Device Description : Alice PDx Sleep Diagnostic System, US

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Actiwatch 2 - 00606959003842 Catalog Number : 1044809

Device Description : Actiwatch 2 System

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

PerforMax - 00606959003866 Catalog Number : 1047426

Device Description : Performax Mask with Entrainment Elbow, Multi Patient Use, Leak 2, Small, USA

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Actiwatch 2 - 00606959003897 Catalog Number : 1048090

Device Description : Actiwatch 2 Device

Device Class : 2

Duns Number: 080728314

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

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