Newport

FDA UDI

Class II (US FDA UDI)

by Newport Medical Instruments

Identity

Trade Name: Newport FDA UDI
Generic Name: Neonatal/adult intensive-care ventilator FDA UDI
Device Name: HT70 Ventilator with Accessories FDA UDI
Model / Reference: HT70M-PT-BR FDA UDI
Description: HT70 Ventilator with Accessories FDA UDI

Identifiers

Primary DI / UDI-DI: 10884521543959 FDA UDI
FDA Product Code: CBK FDA UDI
GMDN Term: Neonatal/adult intensive-care ventilator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5895 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Neonatal/adult intensive-care ventilator

Newport by Newport Medical Instruments — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Neonatal/adult intensive-care ventilator.

Aeroneb Module control cable — Maquet Critical Care AB · Class II
VMAX — VYAIRE MEDICAL, INC. · Class II
Puritan Bennett — Covidien LP · Class II
Neumovent — Tecme Corporation · Class II
Puritan Bennett — Covidien LP · Class II
AVEA II — VYAIRE MEDICAL, INC. · Class II
AVEA™ — VYAIRE MEDICAL, INC. · Class II
Puritan Bennett — Covidien LP · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Newport Medical Instruments

Sources (1)

FDA UDI c5a83315-7bc8-4fe2-b543-c7142be88fee 34 fields · synced May 30, 2026