BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ventilator, emergency, manual (resuscitator)

    Reg #: 1314417 · FEI: 1314417 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    SunMed Group Holdings, LLC dba AirLife
    Registration Number
    1314417
    FEI Number
    1314417
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2710 Northridge Dr NW Ste A
    City
    Grand Rapids
    State
    MI
    ZIP
    49544
    Country
    US

    Regulatory Submissions

    510(k) Number
    K082092

    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
    Ventilator, Emergency, Manual (Resuscitator) BTM
    Attachment, Breathing, Positive End Expiratory Pressure BYE

    Proprietary Names

    Ventilator, emergency, manual (resuscitator) Face Mask Neonate and Infant Disposable

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility