Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006606984

FEI Number

3006606984

Entity Name

Westmed de Mexico, S.A de C.V

City/State/Country

NOGALES Sonora, MX

Establishment Address

AVENIDA EL CASTILLO 17-B, NOGALES Sonora 84094, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SunMed Group Holdings, LLC dba AirLife (Owner Number: 10044795)

Owner / Operator Contact Address

2710 Northridge Drive NW, Suite A, Grand Rapids, MI 49544, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Salter Labs Bubble Humidifier CONNECTOR, AIRWAY Salter Labs NebuTech HDN Reusable Nebulizer WaterPAP Salter Labs 8900 Series Small Volume Jet Nebulizer Westmed Breathing Circuits Nox Medical Filter Salter Humidifier Humidifier nebulizer kit Ballard Metered Dose Inhaler (MDI) Adapter CATHETERS, SUCTION, TRACHEOBRONCHIAL Ballard Single Dose Vials, 0.9% Sodium Chloride Solution NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER) Breathing Tube Support Tube Tree AirLife Bubble Humidifier Nebulizer VixOne Septal H Oxygen Cannula Oxygen Masks Oxygen Tubing Mask Face Tent Disp CANNULA, NASAL, OXYGEN Mask Air Entrain Adult W/u-connect-it Mouthpiece Universal Poly Disp Mask Aerosol Hi-concent Disp Under Chin Etco2 Cannula 7' U/connect-it Adult,male Cannula Crvd N-flr Tip W/o Tb Disp Adapter Trach T Ventlab Pressure Tubing and Accessories Oxygen Tubing AMBU CO2 Easy CO2 Easy APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED Humidifier, bubble, w/3PSI pop-off - 50/cs AirLife GSL Airlife Nebulizer

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	2026-05-06
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2018-04-05
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2026-01-22
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2025-12-11
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2026-01-22
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2026-01-22
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2024-01-04
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2026-06-10
OGG	Humidifier Nebulizer Kit	Anesthesiology	Class 2	868.5450	2023-07-20
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2023-07-18
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2018-01-30
JAY	Support, Breathing Tube	Anesthesiology	Class 1	868.5280	2018-04-09
KFZ	Humidifier, Non-Direct Patient Interface (Home-Use)	Anesthesiology	Class 1	868.5460	2025-11-19
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2023-07-18
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2013-08-02
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2018-01-30
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2018-01-17
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2025-11-19
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2023-07-18
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2026-01-23
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2026-01-23
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2025-12-11
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2025-12-11

Official Correspondent

Rob Yamashita

US Agent Details

Rob Yamashita Business: AirLife Email: ryamashita@myairlife.com Phone: (616) 2598373

Related Public Records

Same Entity

SunMed Group Holdings, LLC dba AirLife

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010362947	Shenzhen Vital Signs-KTL Medical Instrument Co Ltd	Shenzhen Guangdong, CN
3030308442	SUNMED GROUP HOLDINGS, LLC dba AirLife	Litchfield Park, AZ, US
8030647	Westmed de Mexico, S.A de C.V	MAGDALENA Sonora, MX
1314417	SunMed Group Holdings, LLC	Grand Rapids, MI, US
3010838917	AirLife Finland Oy	Helsinki Uusimaa, FI

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
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006606984. Last updated year: 2026. Please use registration number 3006606984 when referencing this establishment in official correspondence.