BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AlcoMate

    DI: 00853464001089 · Model: SM6000 · AK Globaltech Corp
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    AlcoMate
    Primary DI
    00853464001089
    Version / Model
    SM6000
    Catalog Number
    AKG SM6000
    Company Name
    AK Globaltech Corp
    Labeler DUNS
    119201320
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-08-24
    Public Version
    3
    Public Version Date
    2023-06-09
    Public Version Status
    Update
    Public Device Record Key
    f25c6c18-470c-49d8-9f12-9b6700df0dcf

    Device Description

    The First Device featuring PRISM Technology. Global patent including US Patent No. US 7.841.224 B2 & US 8.250.900 B2, Accuracy: +/- 0.01 at 0.10 g/dL (%BAC), Sensor module must be replaced every 200 tests or at least once yearly, whichever comes first.

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OIC Blood Alcohol Kit (Excludes Hiv Testing)
    DJZ Devices, Breath Trapping, Alcohol

    GMDN Terms

    Code Name
    36041 Alcohol breath analyser

    Identifiers

    Type ID
    Primary 00853464001089

    Customer Contacts

    Phone
    201-943-9411
    Email
    [email protected]

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.