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) (9) Circuit, breathing (w connector, adaptor, y piece) (CAI) (1)

Premarket Exempt

No Yes

Clear

Newport - 10884521540736 Catalog Number :

Device Description : Silicon Adult Breathing Circuit with Two Water Trap

Device Class : 1

Duns Number: 050334275

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : No

Device Count : 1

Newport - 10884521540927 Catalog Number :

Device Description : e360 Ventilator with Accessories;E Model

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport - 10884521540934 Catalog Number :

Device Description : e360 Ventilator with Accessories;E Model

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport - 10884521540958 Catalog Number :

Device Description : e360 Ventilator with Accessories;E Model

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport - 10884521541009 Catalog Number :

Device Description : e360 Ventilator with Accessories;E Model

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport - 10884521541023 Catalog Number :

Device Description : e360 VENTILATOR, SPANISH PLUS

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport - 10884521541078 Catalog Number : E360S-CN-NA

Device Description : e360 VENTILATOR, S MODEL CHINESE NA POWER

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport - 10884521541085 Catalog Number :

Device Description : e360 Ventilator with Accessories;S Model

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport - 10884521541115 Catalog Number :

Device Description : e360 Ventilator with Accessories;S Model

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport - 10884521541122 Catalog Number :

Device Description : e360 Ventilator with Accessories;S Model

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

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