BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116)

    Reg #: 3014421917 · FEI: 3014421917 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    O&M Halyard, Inc.
    Registration Number
    3014421917
    FEI Number
    3014421917
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1220 Old Alpharetta Rd Ste 320
    City
    Alpharetta
    State
    GA
    ZIP
    30005
    Country
    US

    Regulatory Submissions

    510(k) Number
    K232812

    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* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116) Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115) 62115 HALYARD* FLUIDSHIELD* Level 2 Procedure Mask Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114)

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility