BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    COOL

    DI: 00885325000757 · Model: 520001 · i-SENS, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    COOL
    Primary DI
    00885325000757
    Version / Model
    520001
    Company Name
    i-SENS, Inc.
    Labeler DUNS
    688840958
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    6b31c7df-4d9d-4ee7-9863-5fd63fc6ca42

    Device Description

    COOL Blood Glucose Meter

    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NBW System, Test, Blood Glucose, Over The Counter

    GMDN Terms

    Code Name
    56684 Home-use/point-of-care glucose analyser IVD, battery-powered

    Identifiers

    Type ID
    Package 20885325000751
    Package 10885325000754
    Primary 00885325000757

    Customer Contacts

    Phone
    855-646-3231
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K103396 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    32 – 122 Degrees Fahrenheit