BEUDAMED
    FDA Registration Active 🇺🇸 United States

    WESTMED, INC.

    Reg #: 2028807 · FEI: 1000374126 · Expires 2026
    View on FDA
    Products
    46
    Proprietary Names
    71
    Establishment Types
    8
    Classifications
    46

    Registration Details

    Registration Name
    WESTMED, INC.
    Registration Number
    2028807
    FEI Number
    1000374126
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5580 S NOGALES HWY
    City
    TUCSON
    State
    AZ
    ZIP
    85706
    Country
    US

    Regulatory Submissions

    510(k) Number
    K932709

    Owner / Operator

    Firm Name
    WESTMED, INC.
    Operator Number
    9006543
    Address
    5580 S. NOGALES HIGHWAY, --
    City
    Tucson
    State
    AZ
    Postal Code
    85706
    Country
    US
    Correspondent
    Peter Tountas

    Products

    Device Name Product Code
    Mask, Gas, Anesthetic BSJ
    Mixer, Breathing Gases, Anesthesia Inhalation BZR
    Drain, Tee (Water Trap) BYH
    Nebulizer (Direct Patient Interface) CAF
    Compressor, Air, Portable BTI
    Cannula, Nasal, Oxygen CAT
    Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
    Filter, Bacterial, Breathing-Circuit CAH
    Clip, Nose BXJ
    Airway, Oropharyngeal, Anesthesiology CAE
    Support, Breathing Tube JAY
    Arterial Blood Sampling Kit CBT
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Attachment, Breathing, Positive End Expiratory Pressure BYE
    Generator, Oxygen, Portable CAW
    Tubing, Pressure And Accessories BYX
    Ventilator, Emergency, Manual (Resuscitator) BTM
    Oxygen Administration Kit OGL
    Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer BZE
    Bandage, Elastic FQM
    Mask, Oxygen, Low Concentration, Venturi BYF
    Accessory To Continuous Ventilator (Respirator) MOD
    Valve, Non-Rebreathing CBP
    Humidifier Nebulizer Kit OGG
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Humidifier, Non-Direct Patient Interface (Home-Use) KFZ
    Catheters, Suction, Tracheobronchial BSY
    Spacer, Direct Patient Interface NVO
    Mask, Oxygen, Non-Rebreathing KGB
    Condenser, Heat And Moisture (Artificial Nose) BYD
    Catheter And Tip, Suction JOL
    Bag, Reservoir BTC
    Monitor, Airway Pressure (Includes Gauge And/Or Alarm) CAP
    Splint, Intranasal Septal LYA
    Set, Tubing And Support, Ventilator (W Harness) BZO
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    Syringe, Irrigating (Non Dental) KYZ
    Anesthesia Breathing Circuit Kit (Adult & Pediatric) OFP
    Bottle, Collection And Trap, Breathing System (Uncalibrated) CBC
    Connector, Airway (Extension) BZA
    Mask, Oxygen BYG
    Tubeless Analysis, Gastric Acidity JLL
    Nebulizer, Medicinal, Non-Ventilatory (Atomizer) CCQ
    Protector, Skin Pressure FMP
    Mouthpiece, Breathing BYP

    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 Anesthesia Breathing Circuit Kit Westmed Collection Westmed ABG Arterial Blood Gas (ABG), Westmed BARBED CONNECTOR AIRWAY EXTENSION CHRISTMAS TREE CONECTOR SWIVEL CONNECTOR Tracheostomy Mask, Westmed Westmed Masks Feed Safe pH Indicator Nebulizer LARGE HEART Septal-H

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198 Reprocess Single-Use Device Remanufacture Medical Device Sterilize Medical Device for Another Party (Contract Sterilizer)