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) (7) Circuit, breathing (w connector, adaptor, y piece) (CAI) (2) Ventilator, continuous, facility use (CBK) (1)

Premarket Exempt

No Yes

Clear

Newport - 10884521510821 Catalog Number :

Device Description : e360 Ventilator with Accessories T Model

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport - 10884521510838 Catalog Number :

Device Description : e360 Ventilator with Accessories T Model

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport - 10884521510845 Catalog Number :

Device Description : e360 Ventilator with Accessories T Model

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport - 10884521510852 Catalog Number :

Device Description : e360 Ventilator with Accessories;T Model

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport - 10884521510869 Catalog Number : E360T-RU-IN

Device Description : e360 Ventilator with Accessories T Model

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport - 10884521511279 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 - 10884521511774 Catalog Number :

Device Description : e360 Ventilator with Accessories T Model

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport Medical - 10884521511903 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 Medical - 10884521540514 Catalog Number :

Device Description : Pediatric (15 mm ID) Abbreviated (Partical) J Ventilation Breathing Circuit

Device Class : 1

Duns Number: 050334275

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : Yes

Device Count : 1

Newport Medical - 10884521540521 Catalog Number :

Device Description : Pediatric Ventilation Breathing Circuit

Device Class : 1

Duns Number: 050334275

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : Yes

Device Count : 1

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