BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SEA-LONG MEDICAL SYSTEMS, LLC

    Reg #: 3013976593 · FEI: 1037230 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    SEA-LONG MEDICAL SYSTEMS, LLC
    Registration Number
    3013976593
    FEI Number
    1037230
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2498 FM66, Building 1021
    City
    Waxahachie
    State
    TX
    ZIP
    75167
    Country
    US

    Regulatory Submissions

    510(k) Number
    K010659

    Owner / Operator

    Firm Name
    Sea-long Medical Systems, LLC
    Operator Number
    10056562
    Address
    135 Tranquil Pl.
    City
    Waxahachie
    State
    TX
    Postal Code
    75167
    Country
    US
    Correspondent
    Melissa Nogic

    Products

    Device Name Product Code
    Hood, Oxygen, Infant FOG
    Tent, Oxygen BYL
    Chamber, Hyperbaric CBF

    Proprietary Names

    HBOT Oxygen Hood PN5000 Series Sea-Long Medical Helmet

    Establishment Types

    Manufacture Medical Device