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) Filter, bacterial, breathing-circuit (CAH) (1) Ventilator, Continuous, Facility Use (CBK) (1)

Premarket Exempt

No Yes

Clear

Newport - 10884521541269 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 - 10884521541276 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 - 10884521541283 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 - 10884521541290 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 - 10884521541306 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 - 10884521541320 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 - 10884521541399 Catalog Number :

Device Description : Filter, Bacteria

Device Class :

Duns Number: 050334275

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 50

Newport Medical - 10884521541467 Catalog Number :

Device Description : Filters

Device Class :

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 5

Newport Medical - 10884521541979 Catalog Number :

Device Description : PED-ADLT REUSBLE NT CCT W/EXHV

Device Class : 1

Duns Number: 050334275

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : No

Device Count : 1

Newport Medical - 10884521541986 Catalog Number : HT600047

Device Description : PED-ADLT REUSBLE NT CCT W/EXHV

Device Class : 1

Duns Number: 050334275

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : No

Device Count : 1

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