BEUDAMED
    FDA Registration Active 🇮🇳 India

    CSS7100 GUARDIAN REAL-TIME MONITOR

    Reg #: 3018094310 · FEI: 3018094310 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    42
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Medtronic Engineering and Innovation Center (MEIC)
    Registration Number
    3018094310
    FEI Number
    3018094310
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    BSR Tech Park, Survey No.135, 138, 141 & 142 Nanakramguda Main Road
    City
    Hyderabad
    Country
    IN

    Regulatory Submissions

    PMA Number
    P980022

    Owner / Operator

    Firm Name
    Medtronic, Inc.
    Operator Number
    2112641
    Address
    710 Medtronic Parkway
    City
    Minneapolis
    State
    MN
    Postal Code
    55432
    Country
    US

    US Agent

    Business Name
    MEDTRONIC, INC.
    Contact Name
    Tania Pearson
    Address
    3576 Unocal Pl
    City
    Santa Rosa
    State
    CA
    ZIP
    95403
    Country
    US
    Email
    [email protected]
    Phone
    916 8138456

    Products

    Device Name Product Code
    Sensor, Glucose, Invasive MDS
    Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor OYC

    Proprietary Names

    CSS7100 GUARDIAN REAL-TIME MONITOR MMT-7703 MiniLink REAL-Time Transmitter, Replacement (GST1) MMT-7333 CareLink Personal Therapy Management Software for Diabetes CSS7100k GUARDIAN REAL-TIME MONITOR MMT-522k PARADIGM REAL-time Pump MMT-7301 COM-STATION MMT-7706 MiniLink Tester Plug, Replacement MMT-7334 Medtronic CareLink MMT-723k Paradigm REAL-Time Revel Insulin Pump MMT-7310 CGMS Com-Station Software MMT-7708 CGMS iPro Continuous Glucose Recorder MMT-522 PARADIGM REAL-time Pump MMT-7102 Continuous Glucose Monitor MMT-7340 CareLink iPro CSS72 Guardian REAL-Time Continuous Glucose Monitoring System MMT-523 Paradigm REAL-Time Revel Insulin Pump MMT-7705 MiniLink Transmitter Charger, Replacement (Blue) MMT-7726 Water Tight Tester (Plug), Replacement MMT-7311 SOLUTIONS MMT-722 PARADIGM REAL-time Pump MMT-523k Paradigm REAL-Time Revel Insulin Pump MMT-7745 iPro2 MMT-7315 GUARDIAN SOLUTIONS SOFTWARE MMT-722k PARADIGM REAL-time Pump MMT-7712 CGMS iPro Wand MMT-7709 iPro Digital Recorder MMT-7319 Solutions Software For CGMS iPro CONTINUOUS GLUCOSE RECORDER MMT-7203 MiniMed Cable MMT-7744 iPro2 Cleaning Plugs MMT-723 Paradigm Real-Time Revel Insulin Pump 3ml MMT-7707 MiniLink REAL-Time TRANSMITTER MMT-9101 MYSENTRY MONITOR MMT-551 MINIMED 530G INSULIN PUMPS MMT-753K PARADIGM REAL-TIME REVEL INSULIN PUMPS MMT-753 PARADIGM REAL-TIME REVEL INSULIN PUMPS MMT-9102 MYSENTRY OUTPOST MMT-9100 MYSENTRY SYSTEM MMT-7008 ENLITE GLUCOSE SENSOR MMT-7400 MiniMed Test Plug MMT-751 MINIMED 530G INSULIN PUMPS MMT-7735 MiniLink REAL-Time Transmitter MMT-523 Paradigm Real-Time Revel Insulin Pump 1.8m

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198