Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025889185

FEI Number

3025889185

Entity Name

Novair USA Corp.

City/State/Country

North Tonawanda, NY, US

Establishment Address

814 WURLITZER DR, North Tonawanda, NY 14120, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

Novair USA Corp (Owner Number: 10087032)

Owner / Operator Contact Address

814 WURLITZER DR, North Tonawanda, NY 14120, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NOVAIR - USA NOVAIR Oxygen Generating Systems International

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2023-01-04

Official Correspondent

John Longuil

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Novair USA Corp

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K003939	Invacare Corp.	VENTURE HOME FILL II, MODEL IOH 200	2001-03-21
K942357	Healthdyne, Inc.	H-500 ALLIANCE OXYGEN CONCENTRATOR	1994-05-27
K042262	Sequal Technologies, Inc.	INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10	2004-09-10
K003472	Sequal Technologies, Inc.	INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM	2001-06-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0038-2007	Sunrise Medical	2	DeVilbiss iFill Personal Oxygen Station model number 535D.

Similar Registrations

Registration Number	Establishment Name	Location
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3008841036	Oxus America, Inc.	Orion Township, MI, US
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9611451	FISHER & PAYKEL HEALTHCARE, LTD.	EAST TAMAKI Auckland, NZ
3013095415	VENTEC LIFE SYSTEMS, INC.	Bothell, WA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025889185. Last updated year: 2026. Please use registration number 3025889185 when referencing this establishment in official correspondence.