Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023209222

FEI Number

3023209222

Entity Name

Baja Fur S.A. de C.V.

City/State/Country

Tijuana Baja California, MX

Establishment Address

Calle Guerrero Negro 9965, Colonia Parque Industrial Pacifico Cuarta Etapa, Tijuana Baja California 22643, MX

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

VAPOTHERM, INC. (Owner Number: 9038880)

Owner / Operator Contact Address

100 Domain Drive, --, Exeter, NH 03833, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K221318

PMA Number

N/A

All Registered Proprietary Names

HVT 2 PF-ADPC-LOW HVT 2 HVT 2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2021-11-15
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2008-10-27
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2026-04-16
QAV	High Flow/High Velocity Humidified Oxygen Delivery Device	Anesthesiology	Class 2	868.5454	2023-02-21

Official Correspondent

Neeraj Pardhy

US Agent Details

Michael Webb Business: VAPOTHERM, INC. Email: RegulatoryAffairs@vtherm.com Phone: (603) 6580011

Related Public Records

Same Entity

VAPOTHERM, INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012971441	Vapotherm Inc.	Exeter, NH, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K012633	Respironics, Inc.	RESPIRONICS HEATED HUMIDIFIER	2002-02-28
K970478	Marquest Medical Products, Inc.	SCT 3000 HEATED HUMIDIFIER	1997-07-16

Similar Registrations

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2085602	FISHER & PAYKEL HEALTHCARE, INC.	IRVINE, CA, US
3029906224	Hamilton Medical AG	Domat/Ems Graubunden, CH
3011137372	Teleflex Medical LLC	Morrisville, NC, US
9611451	FISHER & PAYKEL HEALTHCARE, LTD.	EAST TAMAKI Auckland, NZ

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023209222. Last updated year: 2026. Please use registration number 3023209222 when referencing this establishment in official correspondence.