BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    La Ada de Acuna

    Reg #: 9616096 · FEI: 3003807323 · Expires 2026
    View on FDA
    Products
    26
    Proprietary Names
    91
    Establishment Types
    1
    Classifications
    26

    Registration Details

    Registration Name
    La Ada de Acuna
    Registration Number
    9616096
    FEI Number
    3003807323
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    KM 4.5 CARRETERRA PRESA LA, AMISTAD
    City
    CIUDAD DE ACUNA Coahuila
    Country
    MX

    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

    US Agent

    Business Name
    O&M HALYARD, INC.
    Contact Name
    Angela Bunn
    Address
    1220 Old Alpharetta Rd Ste 320
    City
    Alpharetta
    State
    GA
    ZIP
    30005
    Country
    US
    Email
    [email protected]
    Phone
    470 3647147

    Products

    Device Name Product Code
    Mask, Surgical FXX
    Wrap, Sterilization FRG
    Suit, Surgical FXO
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Gown, Surgical FYA
    Stocking, Medical Support (For General Medical Purposes) FQL
    Accessory, Surgical Apparel LYU
    Cover, Shoe, Operating-Room FXP
    Drape, Surgical, Antimicrobial KKX
    Table And Attachments, Operating-Room BWN
    Pack, Hot Or Cold, Disposable IMD
    General Surgery Tray LRO
    Shoe And Shoe Cover, Conductive BWP
    System, Thermal Regulating DWJ
    Pediatric/Child Facemask OXZ
    Patient Personal Hygiene Kit NSB
    Gown, Isolation, Surgical FYC
    Respirator, Surgical MSH
    Stretcher, Patient Restraint NZD
    Bedding, Disposable, Medical KME
    Gown, Examination FME
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Drape, Surgical, Exempt PUI
    Non-Surgical Gown OEA
    Chamber, Patient Isolation LGM
    Cap, Surgical FYF

    Proprietary Names

    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) HALYARD® SEQUENTIAL Sterilization Wrap HALYARD® ONE-STEP® Sterilization Wrap HALYARD® QUICK CHECK® Sterilization Wrap HALYARD® SMART-FOLD® Sterilization Wrap SURGICAL SUIT HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops EYE SHIELD 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) STERILIZATION WRAP Aero Chrome Select Stockinette SURGICAL GOWN 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 HALYARD PROCEDURE GOWN HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Blue, WrapAround Visor HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Blue OPERATING ROOM SHOE COVER GOWN, DRAPE PACKS SURGICAL DRAPE HALYARD OPERATING ROOM TABLE AND ATTACHMENTS DISPOSABLE HOT / COLD PACK General Surgery Tray SURGICAL DRAPE Surgical Packs 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 Anti-Fog Surgical Mask K823078 HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) Aero Blue Performance Surgical Gowns SHOE AND SHOE COVER THERMAL REGULATING SYSTEM HALYARD GOWN PEDIATRIC / CHILD FACEMASK SMART-FOLD Sterilization Wrap AERO BLUE SURGICAL GOWN Patient Welcome Pack Hygiene Kit FLUIDSHIELD* 3 Fog-Free Surgical Mask with So Soft* Lining FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops FLUIDSHIELD* 3 Fog-Free Procedure Mask with So Soft* Lining SURGICAL ISOLATION GOWN Aero Chrome Breathable Performance Surgical Gown PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL PATIENT RESTRAINT Halyard ONE-STEP Sterilization Wrap HALYARD* Level 1 Procedure Mask (48388) HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867) DISPOSABLE MEDICAL BEDDING EXAMINATION GOWN FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805) FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802) FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803) Surgical Gown HALYARD ULTRA SURGICAL GOWN FLUIDSHIELD* 2 Expanded Chamber Surgical Mask with SO SOFT* Lining, High Clarity WrapAround Visor FLUIDSHIELD* 2 Expanded Chamber Surgical Mask with SO SOFT* Lining FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical Mask ISOLATION SURGICAL GOWN STERILIZATION WRAP AND ACCESSORIES Surgical Drape Equipment Covers Surgical Drapes and/or accessories Back Table Covers Halyard Gown Surgical Drapes and/or accessories (Stockinette Drapes) HALYARD BASICS SURGICAL GOWN Procedure Mask Surgical Mask Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869) Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802) SURGICAL CAP

    Establishment Types

    Manufacture Medical Device