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 - 10884521542105 Catalog Number : HT70M-SY-EU

Device Description : HT70 Ventilator With Accessories;O2 Monitor

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport - 10884521542112 Catalog Number : HT70M-SY-NA

Device Description : HT70 Ventilator With Accessories;O2 Monitor

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport - 10884521542129 Catalog Number : HT70M-SY-UK

Device Description : HT70 Ventilator With Accessories;O2 Monitor

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport - 10884521542136 Catalog Number : HT70M-WW-EU

Device Description : HT70 Ventilator With Accessories;O2 Monitor

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport - 10884521542143 Catalog Number :

Device Description : HT70 Ventilator With Accessories;O2 Monitor

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport - 10884521542150 Catalog Number : HT70M-WW-UK

Device Description : HT70 Ventilator With Accessories;O2 Monitor

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport - 10884521542174 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 - 10884521542181 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 - 10884521542198 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 - 10884521542204 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

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