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 - 10884521544284 Catalog Number : HT70PM-CN-NA

Device Description : HT70 Ventilator with Accessories

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport - 10884521544291 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 - 10884521544307 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 - 10884521544321 Catalog Number : HT70PM-JP-NA

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 - 10884521544338 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 - 10884521544345 Catalog Number : HT70PM-RU-EU

Device Description : HT70 Ventilator with Accessories

Device Class : 2

Duns Number: 050334275

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Newport - 10884521544369 Catalog Number : HT70PM-SY-EU

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 - 10884521544376 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 - 10884521544383 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 - 10884521544413 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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