BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HALYARD* Level 1 Procedure Mask (48388)

    Reg #: 3014421917 · FEI: 3014421917 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    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
    K232806

    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* Level 1 Procedure Mask (48388) HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867)

    Establishment Types

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