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

VENTILATOR, CONTINUOUS, FACILITY USE (CBK) (6) Circuit, breathing (w connector, adaptor, y piece) (CAI) (2) ANALYZER, GAS, OXYGEN, GASEOUS-PHASE (CCL) (1) Ventilator, continuous, facility use (CBK) (1)

Premarket Exempt

No Yes

Clear

Newport Medical - 10884521542440 Catalog Number :

Device Description : REUSABLE INFANT CIRCUIT W/PROX

Device Class : 1

Duns Number: 050334275

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : No

Device Count : 1

Newport Medical - 10884521542464 Catalog Number : PBC460A

Device Description : REUSABLE INFANT CIRCUIT W/O PR

Device Class : 2

Duns Number: 050334275

Premarket Exempt : Yes

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport Medical - 10884521542471 Catalog Number :

Device Description : REUSABLE PED CIRCUIT W/O PROX

Device Class : 1

Duns Number: 050334275

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : No

Device Count : 1

Newport Medical - 10884521542617 Catalog Number :

Device Description : Medical Oxygen Sensor

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CCL

Prescription Use : Yes

Device Count : 1

Newport - 10884521543911 Catalog Number :

Device Description : HT70 Ventilator with Accessories

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport - 10884521543928 Catalog Number :

Device Description : HT70 Ventilator with Accessories

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport - 10884521543942 Catalog Number :

Device Description : HT70 Ventilator with Accessories

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport - 10884521543959 Catalog Number :

Device Description : HT70 Ventilator with Accessories

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport - 10884521543966 Catalog Number : HT70M-RU-EU

Device Description : HT70 Ventilator with Accessories

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport - 10884521544062 Catalog Number :

Device Description : HT70 Ventilator with Accessories O2 Monitor

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

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