BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SOMNETICS INTERNATIONAL, INC

    Reg #: 3008770104 · FEI: 3008770104 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    SOMNETICS INTERNATIONAL, INC
    Registration Number
    3008770104
    FEI Number
    3008770104
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    103 Osborne Road NE
    City
    Fridley
    State
    MN
    ZIP
    55432
    Country
    US

    Regulatory Submissions

    510(k) Number
    K180388

    Owner / Operator

    Firm Name
    Somnetics International, Inc
    Operator Number
    10036212
    Address
    103 Osborne Road NE
    City
    Fridley
    State
    MN
    Postal Code
    55432
    Country
    US
    Correspondent
    Adrienne Schroll

    Products

    Device Name Product Code
    Tubing, Pressure And Accessories BYX
    Ventilator, Non-Continuous (Respirator) BZD
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    Condenser, Heat And Moisture (Artificial Nose) BYD

    Proprietary Names

    Transcend AirFlex Transcend WhisperSoft Transcend 365 miniCPAP Auto Transcend 365 miniCPAP Transcend Auto Transcend 3 miniCPAP Auto Transcend EZEX Transcend 3 miniCPAP Transcend Micro Transcend Heated Humidifier Transcend Sleep Apnea Therapy System Transcend AirMist

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility