BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    DM-1000 Nasal CO2 Sampling Line

    Reg #: 9710116 · FEI: 3003348851 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DISPO-MED (MALAYSIA) SDN BHD
    Registration Number
    9710116
    FEI Number
    3003348851
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 3, Jalan Meteor U16/153A, Elmina, Sekysen 16
    City
    Shah Alam Selangor
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K143127

    Owner / Operator

    Firm Name
    Dispo-Med (MALAYSIA) SDN BHD
    Operator Number
    10048710
    Address
    No. 3, Jalan Meteor U16/153A, Elmina, Sekysen 16
    City
    Shah Alam
    State
    Selangor
    Postal Code
    40160
    Country
    MY
    Correspondent
    NC Leow

    US Agent

    Business Name
    ProMedic, LLC
    Contact Name
    Matt Dryden Dryden
    Address
    131 Bay Point Dr NE
    City
    Saint Petersburg
    State
    FL
    ZIP
    33704
    Country
    US
    Email
    [email protected]
    Phone
    239 3076063

    Products

    Device Name Product Code
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK

    Proprietary Names

    DM-1000 Nasal CO2 Sampling Line DM-7100 Gas Sampling Line DM-4601 Nasal/Oral O2 and CO2 Sampling Cannula DM-4000 Nasal CO2 Sampling Cannula w/ O2 Delivery DM-7700 Gas Sampling Line with T-Connector & Filter Gas Sampling Cannula O2 Cannula DM-6500 DUO Flow O2 and CO2 Sampling Cannula DM-4100 CO2 Sampling Cannula with Filter DM-4441 LO-FLO CO2 Sampling Cannual with Dual O2 Delivery Gas Sampling Line CO2 Sampling Cannula w/ O2 Delivery Line CO2-MAS Capnomask O2 + CO2 Sampling Mask

    Establishment Types

    Manufacture Medical Device