Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005587132

FEI Number

3005587132

Entity Name

Westmed Javid de Mexico, S.A. de C.V.

City/State/Country

NOGALES Sonora, MX

Establishment Address

CARRETERA INTERNACIONAL KM 6.5, Edif 18; Parque Industrial Nogales, NOGALES Sonora 84094, MX

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

WESTMED, INC. (Owner Number: 9082601)

Owner / Operator Contact Address

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

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Wound Irrigation Kit Manual Pulmonary Resuscitator Condensation Trap Salter Labs Bubble Humidifier CIRCULAIRE II CIRCULAIRE A-Line ABG without Needle Westmed Filter AirFlow Resuscitator FloCap VIXONE Muc-Away Airway ABG Pulset Atellica VTR PEP Device Anesthesia Breathing Circuit Humidifier Westmed tubing Anesthesia Breathing Circuit Kit Airway Connector Hyperinflation System STAT-Check Resuscitator Westmed Cannula Vented Luer Tip Cap Water Trap Respiratory Device Accessories

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PXY	Irrigation Kit (Wounds)	General, Plastic Surgery	Class 1	878.4014	2022-06-08
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2022-05-10
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2015-09-10
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2021-07-28
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
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2017-09-25
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2009-12-16
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2017-09-01
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2017-09-01
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	Class 2	868.2600	2017-09-01
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2020-04-24
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2009-08-24
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2022-05-10
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2023-05-04
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2017-09-01
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2009-12-16
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2020-06-11
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2009-12-16
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2017-05-19
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2017-03-06
OGL	Oxygen Administration Kit	Anesthesiology	Class 2	868.5655	2017-02-14
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2017-09-25
CBT	Arterial Blood Sampling Kit	Anesthesiology	Class 1	868.1100	2012-06-11
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2020-07-08
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2014-08-28
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2017-09-01
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2012-05-30
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2009-08-24
OFP	Anesthesia Breathing Circuit Kit (Adult & Pediatric)	Anesthesiology	Class 1	868.5240	2014-05-09
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2010-08-03
BZR	Mixer, Breathing Gases, Anesthesia Inhalation	Anesthesiology	Class 2	868.5330	2019-02-20
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2022-05-10
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2009-12-16
BXY	Flowmeter, Calibration, Gas	Anesthesiology	Class 1	868.2350	2020-04-22
BYH	Drain, Tee (Water Trap)	Anesthesiology	Class 1	868.5995	2011-03-31
JAY	Support, Breathing Tube	Anesthesiology	Class 1	868.5280	2024-08-09

Official Correspondent

Peter Tountas

US Agent Details

Peter Tountas Business: SunMed Group Holdings LLC, dba AirLife Email: ptountas@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
9710644	WESTMED de Mexico, S.A de C.V.	Tecate Baja California, MX
2028807	WESTMED, INC.	TUCSON, AZ, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K003939	Invacare Corp.	VENTURE HOME FILL II, MODEL IOH 200	2001-03-21
K942357	Healthdyne, Inc.	H-500 ALLIANCE OXYGEN CONCENTRATOR	1994-05-27
K042262	Sequal Technologies, Inc.	INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10	2004-09-10
K003472	Sequal Technologies, Inc.	INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM	2001-06-04
K012633	Respironics, Inc.	RESPIRONICS HEATED HUMIDIFIER	2002-02-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2010	Unomedical	2	Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID # 5801, 12-8713, 732-E, and 2206. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak. Recalled codes may be identified by examining the patient valve housing immediately below the right-angle exhalation port, where the retention ring should be visible. MPR units with a clear or transparent ring, as well as those where no ring can be seen, should be returned. MPR units with a blue retention ring are not affected and do not need to be returned.
Z-0040-2010	Unomedical	2	Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s: 5804; 12-8709, 727-E; 727MM, 2203. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak.
Z-0041-2010	Unomedical	2	Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & Gas Sampling elbow. Product ID # 5807; 12-8703, 723-E (Foreign Distribution only), 723MM. Packaged under the name of Dynarex and Evergreen.
Z-0042-2010	Unomedical	2	Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s 5808, 12-8704; 724-E; 724MM, 32612. Packaged under the name of Dynarex, Evergreen, Hospitak and Select Medical Products.
Z-0043-2010	Unomedical	2	Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & standard elbow. Product ID #: 12-8702; 778500; 721-E, 778500; 2200; 2201, 86-721E, 40-116722 (foreign distributiuon only), 721MM. Packaged under the name of Evergreen, Hospitak, Kentron, McKesson and Mada.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005587132. Last updated year: 2026. Please use registration number 3005587132 when referencing this establishment in official correspondence.