BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HALYARD Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining

    Reg #: 3014421917 · FEI: 3014421917 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    3
    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
    K243010

    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

    HALYARD Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining HALYARD Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor HALYARD Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, WrapAround Visor HALYARD Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor HALYARD Fluidshield * 3 Surgical Mask with SO SOFT* Lining HALYARD Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops, WrapAround Visor HALYARD Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with Visor HALYARD Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor HALYARD Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops HALYARD Fluidshield* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device