BEUDAMED
    FDA Registration Active 🇺🇸 United States

    8570127 (EOL) Unifilter S (Bulk), 557051200 (EOL) Y-filter Plus Edith 1000

    Reg #: 1314417 · FEI: 1314417 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    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
    K043120

    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
    Filter, Bacterial, Breathing-Circuit CAH

    Proprietary Names

    8570127 (EOL) Unifilter S (Bulk), 557051200 (EOL) Y-filter Plus Edith 1000 Filters, M1010541 Angled Uni-Filters/S M1003346 Uni-Filter Junior, M1003345 Uni-Filter Mini, 557022500 Uni-Filter/S, 557021200 U-Filters

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility