Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018114218

FEI Number

3018114218

Entity Name

LOEWENSTEIN MEDICAL AMERICAS CORP.

City/State/Country

Alpharetta, GA, US

Establishment Address

4080 McGinnis Ferry RD, Suite 1303, Alpharetta, GA 30005, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Loewenstein Medical Americas Corp. (Owner Number: 10080914)

Owner / Operator Contact Address

4080 McGinnis Ferry RD, Suite 1303, Alpharetta, GA 30005, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LM High Flow Nasal Cannula

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2021-06-03

Official Correspondent

Tony Costantino

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Loewenstein Medical Americas Corp.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018114218. Last updated year: 2026. Please use registration number 3018114218 when referencing this establishment in official correspondence.