BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PARADIGM® REAL-time

    DI: 00613994622693 · Model: MMT-522NAB · 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
    Primary DI
    00613994622693
    Version / Model
    MMT-522NAB
    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
    2023-07-31
    Public Version Status
    Update
    Public Device Record Key
    ec6db80f-f7ad-42e5-8200-5208104227c4

    Device Description

    PUMP MMT-522NAB PRDGM INS V2.4 BL EN PR

    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 00613994622693

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    P980022 013

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -20 – 55 Degrees Celsius