Newport Medical Instruments, Inc.

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) (10)

Premarket Exempt

No Yes

Clear

Newport - 10884521208940 Catalog Number :

Device Description : HT70PLUS VENT,ENGLISH,NA CORDD, D/L

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport - 10884521208995 Catalog Number :

Device Description : D/L, HT70M Vent

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport - 10884521212183 Catalog Number : E360S-US-NA

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 - 10884521510586 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 - 10884521510593 Catalog Number :

Device Description : E360T1 VENTILATOR BRAZIL, EXPANDED TOUCH HEAD ONLY

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport - 10884521510623 Catalog Number : E360TH-CN-NA

Device Description : E360T VENT,TS HEAD ONLY, CHIN

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport - 10884521510760 Catalog Number : E360S-ES-NA

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 - 10884521510784 Catalog Number :

Device Description : E360T VENT, TS HEAD ONLY,SPAN

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport - 10884521510791 Catalog Number : E360TH-SY-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 - 10884521510807 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

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