BEUDAMED
    FDA Registration Active 🇺🇸 United States

    P2000 FluidSmart Fluid Management system (at the time of clearance, this was called “Thermedx 37-5”)

    Reg #: 3007495879 · FEI: 3007495879 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    THERMEDX, LLC
    Registration Number
    3007495879
    FEI Number
    3007495879
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    31200 Solon Road, Unit 1
    City
    Solon
    State
    OH
    ZIP
    44139
    Country
    US

    Regulatory Submissions

    510(k) Number
    K091939

    Owner / Operator

    Firm Name
    STRYKER CORP.
    Operator Number
    1811755
    Address
    4100 East Milham Ave.
    City
    Kalamazoo
    State
    MI
    Postal Code
    49001
    Country
    US

    Products

    Device Name Product Code
    Insufflator, Hysteroscopic HIG

    Proprietary Names

    P2000 FluidSmart Fluid Management system (at the time of clearance, this was called “Thermedx 37-5”) LL0004 - Tubing Set – Single Lumen Inflow with Dual Outflow LL0002 – Luer Lock Set Single Lumen

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device