BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868)

    Reg #: 3010388894 · FEI: 3010388894 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    O&M Halyard, Inc. (Mechanicsburg)
    Registration Number
    3010388894
    FEI Number
    3010388894
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    500 Independence Ave
    City
    Mechanicsburg
    State
    PA
    ZIP
    17050
    Country
    US

    Regulatory Submissions

    510(k) Number
    K232777

    Owner / Operator

    Firm Name
    O&M Halyard, Inc.
    Operator Number
    10057479
    Address
    1220 Old Alpharetta Rd, Suite 320
    City
    Alpharetta
    State
    GA
    Postal Code
    30005
    Country
    US
    Correspondent
    Angela Bunn

    Products

    Device Name Product Code
    Mask, Surgical FXX

    Proprietary Names

    FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868) FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798)

    Establishment Types

    Repack or Relabel Medical Device