Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9710644

FEI Number

3003949221

Entity Name

WESTMED de Mexico, S.A de C.V.

City/State/Country

Tecate Baja California, MX

Establishment Address

BLVD ENCINO 100, Parque Industrial Tecate, Tecate Baja California 21430, MX

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

WESTMED, INC. (Owner Number: 9048311)

Owner / Operator Contact Address

5580 S. Nogales Hwy, --, Tucson, AZ 85706, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K162343

PMA Number

N/A

All Registered Proprietary Names

Heated wick circuit Clear Anesthesia CLEAR ANESTHESIA BRE Circulaire System ApnealInk ResMed Cannula Westmed Mask Nasal Cannula Neo-Vent HEPA fILTER w/o CO2 Filter Anapod Breathing Bag Westmed Tubing Lavabed Anesthesia Breathing Circuit Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	Anesthesiology	Class 2	868.5270	2013-03-14
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2004-01-08
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2004-01-08
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2017-06-06
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2017-09-01
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2017-09-25
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2008-08-25
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2017-09-01
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2008-08-26
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	Class 2	868.2600	2017-09-01
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2021-07-28
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2017-09-01
MOD	Accessory To Continuous Ventilator (Respirator)	Anesthesiology	Class 2	868.5895	2019-07-01
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2019-12-19
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2008-08-26
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2017-09-25
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2008-06-27
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2004-01-08
OFP	Anesthesia Breathing Circuit Kit (Adult & Pediatric)	Anesthesiology	Class 1	868.5240	2014-05-09
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2017-09-25
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2017-09-25

Official Correspondent

Peter Tountas

US Agent Details

Rob Yamashita Business: SunMed Group Holdings, LLC dba AirLife Email: ryamashita@myairlife.com Phone: (616) 2598373

Related Public Records

Same Entity

WESTMED, 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
2028807	WESTMED, INC.	TUCSON, AZ, US
3005587132	Westmed Javid de Mexico, S.A. de C.V.	NOGALES Sonora, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26
K142467	Abeon Medical Corporation	IntelAir Nasal Airway Support System	2014-11-24
K861213	Datex Division Instrumentarium Corp.	PB 254 IR - SPECTROMETER	1986-04-04
K172904	Philips Medizin Systeme Boeblingen GmbH	IntelliVue Capnography Extension, IntelliVue Microstream Extension	2017-12-26
K812140	3M Company	BIRD MEAN AIRWAY PRESSURE MONITOR	1981-08-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Z-0025-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Z-0026-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
Z-0027-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03

Similar Registrations

Registration Number	Establishment Name	Location
1417592	MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, US
8030673	PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.	MEXICALI Baja California, MX
3023272766	CEVA LOGISTICS LIMITED	Daventry Northamptonshire, GB
3014766741	Hamilton Medical AG	Domat / Ems Graubunden, CH
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 9710644. Last updated year: 2026. Please use registration number 9710644 when referencing this establishment in official correspondence.