BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Vision Express

    DI: 00812345027082 · Model: BURV53H-5 · MORTARA INSTRUMENT, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Vision Express
    Primary DI
    00812345027082
    Version / Model
    BURV53H-5
    Company Name
    MORTARA INSTRUMENT, INC.
    Labeler DUNS
    062046149
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    3
    Public Version Date
    2020-06-29
    Public Version Status
    Update
    Public Device Record Key
    96c1deca-93ff-4361-8c62-5ef839eb9e19

    Device Description

    Holter Analysis System

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    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
    DQK Computer, Diagnostic, Programmable

    GMDN Terms

    Code Name
    41651 Electrocardiographic long-term ambulatory recording analyser application software

    Identifiers

    Type ID
    Primary 00812345027082

    Customer Contacts

    Phone
    888-667-8272
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Humidity
    Temperature Range
    – 95 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    – 149 Degrees Fahrenheit