Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2028807

FEI Number

1000374126

Entity Name

WESTMED, INC.

City/State/Country

TUCSON, AZ, US

Establishment Address

5580 S NOGALES HWY, TUCSON, AZ 85706, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

WESTMED, INC. (Owner Number: 9006543)

Owner / Operator Contact Address

5580 S. NOGALES HIGHWAY, --, Tucson, AZ 85706, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Westmed Mask Hyperinflation, Westmed DISPOSABLE MEDICAL HYPERINFLATION O2 Composite Respiratory Kit, Starter, Westmed BIFLO Nasal Cannula Ear Cushions, Westmed BIFLO NASAL CANNULA Composite Respiratory Kit, Hospice Care, Westmed Bacterial/ Viral Filter Westmed Westmed HME filters Piston, Syringe Anapod Pedi CO2 PEEP Valve, Neo-Vent Condensation Trap In Line Water Trap, Westmed Tubing with Connectors, Westmed Westmed tubing Adult BagEasy Oxygen Administration Kit CO2 Easy, Westmed CO2 Easy SIMPLEX UNIVERSAL H Circulaire MANOMETER WESTMED CIRCULAIRE PEP DEVICES HEPA Filter HMEF IV HEART MINIHEART HI FLO MINIHEART LO FLOW Mosquito Marksman Pulset A-line Bubble Humidifier, Westmed Westmed Humidifier Micro spacer NON-REBREATHER MASK FAN JET PEDI NEB VIXTWO(HIFLO) INFANT NEB VIXONE Child/ Infant BagEasy Bag Easy, Westmed UNIHEART AEROSOL CHARGING ADAPTOR Bi Level Circuit Accessory Kit, Westmed Westmed Yankauer LATEX OR NEOPRENE ANE Turbinate Glove Lavapak Temperature Controller Lavabed System and Chamber NeoPod T, Westmed Splash Shield Oval Winshield, Winshield, Westmed WINSHIELD

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2009-03-26
BZR	Mixer, Breathing Gases, Anesthesia Inhalation	Anesthesiology	Class 2	868.5330	2004-01-08
BYH	Drain, Tee (Water Trap)	Anesthesiology	Class 1	868.5995	2017-09-01
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2017-09-01
BTI	Compressor, Air, Portable	Anesthesiology	Class 2	868.6250	2017-09-01
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	1992-12-11
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2017-05-01
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2009-03-26
BXJ	Clip, Nose	Anesthesiology	Class 1	868.6225	2017-02-17
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2017-09-01
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2017-09-01
JAY	Support, Breathing Tube	Anesthesiology	Class 1	868.5280	2017-07-07
CBT	Arterial Blood Sampling Kit	Anesthesiology	Class 1	868.1100	2017-09-01
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2019-12-19
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2009-12-16
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2016-03-01
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2017-09-01
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	1997-01-28
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2009-12-16
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2009-12-16
OGL	Oxygen Administration Kit	Anesthesiology	Class 2	868.5655	2017-04-19
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2007-03-02
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	Anesthesiology	Class 2	868.5270	2004-01-08
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2017-09-01
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2009-12-16
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	1996-09-12
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2017-07-07
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2017-07-17
MOD	Accessory To Continuous Ventilator (Respirator)	Anesthesiology	Class 2	868.5895	2014-08-28
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2017-09-01
OGG	Humidifier Nebulizer Kit	Anesthesiology	Class 2	868.5450	2017-08-18
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2017-09-01
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2014-08-28
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2011-05-09
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	1998-03-06
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2008-11-17
KFZ	Humidifier, Non-Direct Patient Interface (Home-Use)	Anesthesiology	Class 1	868.5460	2009-03-26
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2017-09-01
NVO	Spacer, Direct Patient Interface	Anesthesiology	Class 2	868.5630	2021-01-12
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2004-01-08
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	1992-12-11
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2009-12-16
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2011-05-09
CBT	Arterial Blood Sampling Kit	Anesthesiology	Class 1	868.1100	2017-09-01
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2017-09-01
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2000-04-06
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2009-12-16
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2017-09-08
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2004-01-08
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	Class 2	868.2600	2017-09-01
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2013-03-12
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2017-05-11
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2008-07-14
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2004-01-08

Official Correspondent

Peter Tountas

US Agent Details

No US Agent registered (Local establishment).

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
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
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07
K900686	Medical Industries America, Inc.	MAXI COMPRESSORS	1990-04-26
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26
K142467	Abeon Medical Corporation	IntelAir Nasal Airway Support System	2014-11-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2014	King Systems Corp.	1	King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
Z-0033-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83124-2
Z-0034-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, ported elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83100-24
Z-0035-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, 40 cm H2O Popoff elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83144-24
Z-0036-04	VIASYS Med Systems	1	Hyperinflation Circuit, consisting of a 2.0 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve and ported elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83120

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2028807. Last updated year: 2026. Please use registration number 2028807 when referencing this establishment in official correspondence.