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: e360 Ventilator with Accessories;T Model FDA UDI
Model / Reference: E360T-SY-NA FDA UDI
Description: e360 Ventilator with Accessories;T Model FDA UDI

Identifiers

Primary DI / UDI-DI: 10884521511385 FDA UDI
510(k) Number: K101803 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

Yes

FDA UDI

Over-the-Counter

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

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Cleared under the same submission

K101803 also covers:

Newport — Covidien LP
Newport Medical — Covidien LP
Newport — Newport Medical Instruments
Newport — Newport Medical Instruments
Newport — Newport Medical Instruments
Newport — Newport Medical Instruments
Newport Medical — Newport Medical Instruments

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

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Manufacturer

Manufacturer: Newport Medical Instruments

Sources (1)

FDA UDI 1f532afc-3ca3-4bc0-83bd-e18ed4b2152e 36 fields · synced May 30, 2026