BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    AVIVO™

    DI: 00763000065713 · Model: AVIVO1T · MEDTRONIC, INC.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AVIVO™
    Primary DI
    00763000065713
    Version / Model
    AVIVO1T
    Company Name
    MEDTRONIC, INC.
    Labeler DUNS
    006261481
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-01-06
    Public Version
    7
    Public Version Date
    2021-11-10
    Public Version Status
    Update
    Public Device Record Key
    83bda5b4-60a6-4b39-b3ce-1889aa75c5e3
    Distribution End Date
    2018-07-17

    Device Description

    EXT CARDIAC AVIVO1T TRAN US PHAR TUV

    Device Characteristics

    Single Use
    Yes
    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
    DSB PLETHYSMOGRAPH, IMPEDANCE
    MHX MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
    DSI DETECTOR AND ALARM, ARRHYTHMIA

    GMDN Terms

    Code Name
    33586 General-purpose multi-parameter bedside monitor

    Identifiers

    Type ID
    Primary 00763000065713

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K153160 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -20 – 65 Degrees Celsius