BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Paradigm® REAL-Time Revel™

    DI: 00613994755124 · Model: MMT-523KLNL · MEDTRONIC MINIMED, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Paradigm® REAL-Time Revel™
    Primary DI
    00613994755124
    Version / Model
    MMT-523KLNL
    Company Name
    MEDTRONIC MINIMED, INC.
    Labeler DUNS
    849626338
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2014-09-23
    Public Version
    5
    Public Version Date
    2023-09-04
    Public Version Status
    Update
    Public Device Record Key
    3cf8fb56-fabe-420a-9355-b6ab8551c786

    Device Description

    PUMP MMT-523KLNL PRDGM INS V2.3 CL EN

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MDS Sensor, glucose, invasive

    GMDN Terms

    Code Name
    64889 Ambulatory insulin infusion pump, electronic, non-software-dosing

    Identifiers

    Type ID
    Primary 00613994755124

    Customer Contacts

    Phone
    +1(800)633-8766
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    P980022 031

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -20 – 50 Degrees Celsius