Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017171515

FEI Number

3017171515

Entity Name

BREATHH INC

City/State/Country

San Diego, CA, US

Establishment Address

2295 Paseo De Las Americas, Suite 19, San Diego, CA 92154, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Breathh Inc (Owner Number: 10076872)

Owner / Operator Contact Address

2295 Paseo De Las Americas, Suite 19, San Diego, CA 92154, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Lutema M4PFM Lutema M96i Lutema M3PFMC Lutema M95i Lutema M3PFM Lutema M93i Lutema M93c Lutema M4PFMC Lutema M95c Lutema M94k VIDA KF94 VIDA Litespun VIDA KN95

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-08-03

Official Correspondent

Amir Tafreshi

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Breathh Inc

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 3017171515. Last updated year: 2026. Please use registration number 3017171515 when referencing this establishment in official correspondence.