BEUDAMED
    FDA Registration Active 🇺🇸 United States

    O&M Halyard, Inc. (La Ada de Acuna)

    Reg #: 3016849443 · FEI: 3016849443 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    23
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    O&M Halyard, Inc. (La Ada de Acuna)
    Registration Number
    3016849443
    FEI Number
    3016849443
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    14 Finegan Road
    City
    Del Rio
    State
    TX
    ZIP
    78840
    Country
    US

    Regulatory Submissions

    510(k) Number
    K974068

    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
    Respirator, Surgical MSH
    Mask, Surgical FXX

    Proprietary Names

    PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114) Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116) 62115 HALYARD* FLUIDSHIELD* Level 2 Procedure Mask Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115) FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical Mask HALYARD Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops HALYARD Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops, WrapAround Visor HALYARD Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining HALYARD Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare 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 Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor HALYARD Fluidshield * 3 Surgical Mask with SO SOFT* Lining HALYARD Fluidshield* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops HALYARD Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, WrapAround Visor SURGICAL MASK FLUIDSHIELD* 2 Procedure Mask with SO SOFT* Earloops FLUIDSHIELD* 2 Fog-Free Procedure Mask with SO SOFT* Earloops, Blue, WrapAround Visor FLUIDSHIELD* 2 Fog-Free Surgical Mask, Blue with Orange Print FLUIDSHIELD* 2 Fog-Free Surgical Mask, Blue with Orange Print, WrapAround Visor FLUIDSHIELD* 2 Procedure Mask with SO SOFT* Earloops, Blue Fluidshield* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Orange

    Establishment Types

    Manufacture Medical Device