BEUDAMED
    FDA Registration Active 🇺🇸 United States

    P-2122

    Reg #: 2131400 · FEI: 1000116410 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    27
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ENTHERMICS MEDICAL SYSTEMS, INC.
    Registration Number
    2131400
    FEI Number
    1000116410
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    WEST 164 NORTH 9221 WATER ST.
    City
    MENOMONEE FALLS
    State
    WI
    ZIP
    53051
    Country
    US

    Regulatory Submissions

    510(k) Number
    K132202

    Owner / Operator

    Firm Name
    ENTHERMICS MEDICAL SYSTEMS, INC.
    Operator Number
    9027259
    Address
    WEST 164 NORTH 9221 WATER ST., --
    City
    Menomonee Falls
    State
    WI
    Postal Code
    53051
    Country
    US
    Correspondent
    Nicole - Polley

    Products

    Device Name Product Code
    Warmer, Thermal, Infusion Fluid LGZ

    Proprietary Names

    P-2122 DC250L DC400L GET350L EC1850BL EC250L P-2150 EC350L GET250L P-2147 GET1850BL P-2112 EC1350BL MED2275 P-2430 GET550BL MED2428-L MEDIVNEXT P-2420 ivNext GET1350BL EC550BL MED2926 MED2422-L EC400L MED2975 MED2226

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)