BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Exhalation filter

    Reg #: 1526863 · FEI: 1526863 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ICU Medical, Inc.
    Registration Number
    1526863
    FEI Number
    1526863
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    6250 Shier Rings Rd
    City
    DUBLIN
    State
    OH
    ZIP
    43016
    Country
    US

    Regulatory Submissions

    510(k) Number
    K014115

    Owner / Operator

    Firm Name
    ICU Medical, Inc.
    Operator Number
    8020727
    Address
    951 Calle Amanecer
    City
    San Clemente
    State
    CA
    Postal Code
    92673
    Country
    US
    Correspondent
    Michelle Doherty

    Products

    Device Name Product Code
    Ventilator, Emergency, Manual (Resuscitator) BTM

    Proprietary Names

    Exhalation filter Portex 1st Response Adult Manual Resuscita PEEP Valve

    Establishment Types

    Repack or Relabel Medical Device