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) (8) ANALYZER, GAS, OXYGEN, GASEOUS-PHASE (CCL) (1) Circuit, breathing (w connector, adaptor, y piece) (CAI) (1)

Premarket Exempt

No Yes

Clear

Newport - 10884521542211 Catalog Number :

Device Description : HT70 Ventilator With Accessories;Plus Model

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport - 10884521542228 Catalog Number :

Device Description : HT70 Ventilator With Accessories Plus Model

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport - 10884521542235 Catalog Number :

Device Description : HT70 Ventilator With Accessories Plus Model

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport - 10884521542242 Catalog Number :

Device Description : HT70 Ventilator With Accessories Plus Model

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport - 10884521542259 Catalog Number :

Device Description : HT70 Ventilator With Accessories;Plus Model

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport - 10884521542266 Catalog Number :

Device Description : HT70 Ventilator With Accessories Plus Model

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport - 10884521542273 Catalog Number :

Device Description : HT70 Ventilator With Accessories;Plus Model

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport Medical - 10884521542389 Catalog Number :

Device Description : Oxygen Analyzer

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CCL

Prescription Use : Yes

Device Count : 1

Newport Medical - 10884521542396 Catalog Number :

Device Description : REUSBLE ADLT CCT W/PROX, HTD W

Device Class : 2

Duns Number: 050334275

Premarket Exempt : Yes

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport Medical - 10884521542402 Catalog Number :

Device Description : REUSABLE ADULT CIRCUIT W/O PRO

Device Class : 1

Duns Number: 050334275

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : No

Device Count : 1

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