BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OXILINE LLC

    Reg #: 3018940143 · FEI: 3018940143 · Expires 2026
    View on FDA
    Products
    18
    Proprietary Names
    29
    Establishment Types
    1
    Classifications
    18

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    Registration Details

    Registration Name
    OXILINE LLC
    Registration Number
    3018940143
    FEI Number
    3018940143
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    140 NW 37th ST
    City
    Miami
    State
    FL
    ZIP
    33127
    Country
    US

    Regulatory Submissions

    510(k) Number
    K142687

    Owner / Operator

    Firm Name
    OXILINE LLC
    Operator Number
    10081725
    Address
    140 NW 37th ST
    City
    Miami
    State
    FL
    Postal Code
    33127
    Country
    US
    Correspondent
    Juan Parra

    Products

    Device Name Product Code
    Oximeter DQA
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Analyzer, Body Composition, Exempt PUH
    System, Test, Blood Glucose, Over The Counter NBW
    Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature QRK
    Multiple Use Blood Lancet For Single Patient Use Only QRL
    Computer, Diagnostic, Programmable DQK
    Adjunctive Predictive Cardiovascular Indicator QAQ
    Plethysmograph, Impedance DSB
    Oximeter, Tissue Saturation MUD
    Cannula, Catheter DQR
    Electrode, Cutaneous GXY
    Self-Fitting Air-Conduction Hearing Aid, Over The Counter QUH
    Stimulator, Nerve, Transcutaneous, Over-The-Counter NUH
    Stimulator, Muscle, Powered, For Muscle Conditioning NGX
    Orthosis, Lumbar IQE
    Glucose Oxidase, Glucose CGA
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    Pulse MD PRO Pulse Oximeter BM1000A; Pulse Oximeter BM2000A Electronic Blood Pressure Monitor Pressure X Pro Scale XS Pro Scale MD Pro Gluxo XS Pro System, test, blood glucose, over the counter Lancets Therma XS Pro Electrode, cutaneous Elite-X Pads Hear 9S Pro Hear XS Pro Tens XS PRO STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER System measurement Pressure XS Mini Pulse XS Pro Pulse 9S Pro Oximeter TENS Q Pro Gluco XS Pro Andesfit ADF-B27 blood glucose monitoring system; Bioland blood glucose monitoring system; Bioland G-427B blood glucose Gluco X Pro Pressure 9S Pro System, measurement, blood-pressure, non-invasive Pressure XS Pro Pulse Oximeter AOJ-70A, AOJ-70B, AOJ-70C, AOJ-70D, AOJ-70E

    Establishment Types

    Repack or Relabel Medical Device