Newport Medical Instruments, Inc.

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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

Circuit, breathing (w connector, adaptor, y piece) (CAI) (1) VENTILATOR, CONTINUOUS, FACILITY USE (CBK) (1) Ventilator, continuous, facility use (CBK) (1)

Premarket Exempt

No Yes

Clear

Newport Medical - 10884521544444 Catalog Number :

Device Description : KIT, PED/ ADULT AIRWAY FLOW SENSOR, BOX OF 4

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport Medical - 10884521649934 Catalog Number :

Device Description : Permanent Adult/Ped Circuit W/O Water Trap and Exhalation Valve

Device Class : 1

Duns Number: 050334275

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : No

Device Count : 1

Newport Medical - 10884521649941 Catalog Number :

Device Description : Perm. 15MM/Ped Circuit W/O Water Trap and Exhalation Valve

Device Class : 2

Duns Number: 050334275

Premarket Exempt : Yes

Product Code : CBK

Prescription Use : No

Device Count : 1

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