BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SUNMED GROUP HOLDINGS, LLC dba AirLife

    Reg #: 3030308442 · FEI: 3030308442 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    7

    Registration Details

    Registration Name
    SUNMED GROUP HOLDINGS, LLC dba AirLife
    Registration Number
    3030308442
    FEI Number
    3030308442
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    15152 W. Camelback Rd.
    City
    Litchfield Park
    State
    AZ
    ZIP
    85340
    Country
    US

    Regulatory Submissions

    510(k) Number
    K853146

    Owner / Operator

    Firm Name
    SunMed Group Holdings, LLC dba AirLife
    Operator Number
    10044795
    Address
    2710 Northridge Drive NW, Suite A
    City
    Grand Rapids
    State
    MI
    Postal Code
    49544
    Country
    US
    Correspondent
    Rob Yamashita

    Products

    Device Name Product Code
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    Tube, Aspirating, Flexible, Connecting BYY
    Ventilator, Emergency, Manual (Resuscitator) BTM
    Attachment, Breathing, Positive End Expiratory Pressure BYE
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Calculator, Predicted Values, Pulmonary Function BTY
    Humidifier Nebulizer Kit OGG

    Proprietary Names

    HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) Nebulizers Large Volume Prefilled And Dry TUBE, ASPIRATING, FLEXIBLE, CONNECTING Face Mask Neonate and Infant Disposable Ventilator, emergency, manual (resuscitator) CABLE, TRANSDUCER AND ELECTRODE, PATIENT CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION Humidifier nebulizer kit

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device