BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    In Touch Glucose Control Solution

    DI: 00853553005158 · Model: In Touch · LIVONGO HEALTH, INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    In Touch Glucose Control Solution
    Primary DI
    00853553005158
    Version / Model
    In Touch
    Catalog Number
    OFG00155
    Company Name
    LIVONGO HEALTH, INC
    Labeler DUNS
    829984561
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    4
    Public Version Date
    2025-08-21
    Public Version Status
    Update
    Public Device Record Key
    91a837f7-d71b-4904-a99b-d920b4e98288
    Distribution End Date
    2017-12-31

    Device Description

    In Touch Control solution with 1 bottle high, 1 bottle low

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

    GMDN Terms

    Code Name
    41819 Glucose IVD, control

    Identifiers

    Type ID
    Primary 00853553005158

    Customer Contacts

    Phone
    800.945.4355
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K133584 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    41 – 86 Degrees Fahrenheit
    Type
    Storage Environment Humidity
    Temperature Range
    10 – 90 Percent (%) Relative Humidity