BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    Salter Labs de Mexico de S.A. de C.V.

    Reg #: 3010272829 · FEI: 3010272829 · Expires 2026
    View on FDA
    Products
    29
    Proprietary Names
    62
    Establishment Types
    3
    Classifications
    29

    Registration Details

    Registration Name
    Salter Labs de Mexico de S.A. de C.V.
    Registration Number
    3010272829
    FEI Number
    3010272829
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Blvd. Independencia #2167, Parque Ind. Las Americas - Horizonte Sur. Cd. Juarez
    City
    Chihuahua Mexico
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K133806

    Owner / Operator

    Firm Name
    SunMed "also trading as AirLife"
    Operator Number
    9038422
    Address
    2710 Northridge Drive NW, Suite A
    City
    Grand Rapids
    State
    MI
    Postal Code
    49544
    Country
    US
    Correspondent
    Rob Yamashita

    US Agent

    Business Name
    AirLife
    Contact Name
    Rob Yamashita
    Address
    2710 Northridge Drive NW - Suite A
    City
    Grand Rapids
    State
    MI
    ZIP
    49544
    Country
    US
    Email
    [email protected]
    Phone
    616 2598373

    Products

    Device Name Product Code
    Ventilator, Emergency, Manual (Resuscitator) BTM
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Mask, Oxygen BYG
    Nebulizer, Medicinal, Non-Ventilatory (Atomizer) CCQ
    Blood Pressure Cuff DXQ
    Ventilatory Effort Recorder MNR
    Conserver, Oxygen NFB
    Flowmeter, Calibration, Gas BXY
    Nebulizer (Direct Patient Interface) CAF
    Cannula, Nasal, Oxygen CAT
    Mask, Oxygen, Low Concentration, Venturi BYF
    Meter, Peak Flow, Spirometry BZH
    Drain, Tee (Water Trap) BYH
    Connector, Airway (Extension) BZA
    Ventilator, Non-Continuous (Respirator) BZD
    Chamber, Oxygen, Topical, Extremity KPJ
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    Monitor, Breathing Frequency BZQ
    Mask, Oxygen, Non-Rebreathing KGB
    Tape And Bandage, Adhesive KGX
    Device, Fixation, Tracheal Tube CBH
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Blanket, Neonatal Phototherapy PDH
    Tubing, Pressure And Accessories BYX
    Laryngoscope, Rigid CCW
    Infusor, Pressure, For I.V. Bags KZD
    Spirometer, Therapeutic (Incentive) BWF
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Spirometer, Diagnostic BZG

    Proprietary Names

    Airflow resuscitator Capnovue Salter Labs® 8900 Series Small Volume Jet Nebulizer DuraCheck Blood Pressure Cuff ResMed Apnealink Sensor O2 express Liter Meter Salter Labs Nebulizer exhalation filter, 8680 series Salter Style Cannula Salter NebuTech® HDN®Reusable Nebulizer Salter Labs Demand Cannulas ACCU-FLOW Venturi Oxygen System Comfort Soft Plus Cannula Cannula, Nasal, Oxygen, with E-Z wraps VitalCheck Blood Pressure Cuff CO2 Comfort Soft Plus Cannula Salter Labs Peak Flow Meter Salter Labs In Line Water Trap Tilson Trach Guard and Tether Salter Labs nasal cannulas, 16Soft series, 16 series, high flow series, OTC series, gator and ear wraps accessory Comfort Soft Plus CPAP Cannulaide® O2 Boot O2 Sacral Humidifier PneumoTherm ThermiSense Salter Labs Oxygen Mask - Non-rebreathing Mini Heart Nebulizer (Westmed) Grippies, Silicon Strips, MiniWhiskers, StickyWhiskers Sensitive Grips, Tender Grips Salter Labs PEP Device Nebulizer PRO2 PRO2-Elite Luma Wrap Salter Labs Sleep Diagnostic Cannulas, non DEHP ResMed Salter Labs Bubble Humidifier Oxygen tubing, connectors, and accessories Salter Aire Elite Compressor (Apex Minitab) Salter Labs Nebulizer exhalation filter, 8980 series Salter NebuTech® HDN® Disposable Nebulizer IntuBrite Laryngoscope Salter Labs Humidifier 7900 Series; 7900 Series with Cannula Kit Salter Labs Infant Face Mask Salter Labs® Percent-O2-Lock® Venturi System Pressure Infusor Infusor, Disposable, INFUSEIT Infusor, Reusable, INFUSEIT Salter AIRE Plus® THERAPEP DHD Healthcare Corp BiNAPS® Nasal Airflow Pressure and Snore Transducer Salter Labs Elongated Style Adult and Pediatric Style Mask TwinMed -Mask Partial Non-Rebreather Westmed Masks Salter Labs Humidifier Gas Sampling Lines Kit and Gas Tubing Salter Labs EtCO2 sampling cannulas and gas sampling lines, non-DEHP SalterStat Capnography Product Line IGuard Eye Protector Salter Spirometer Disposable blood pressure cuff

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Repack or Relabel Medical Device