BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    GL GoodLife Blood Glucose Monitoring System

    DI: 00389154000617 · Model: AC-11 AC302 · HMD BIOMEDICAL INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    GL GoodLife Blood Glucose Monitoring System
    Primary DI
    00389154000617
    Version / Model
    AC-11 AC302
    Catalog Number
    3K-01-16003N
    Company Name
    HMD BIOMEDICAL INC.
    Labeler DUNS
    658644174
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-12-09
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    8da337b4-92e9-47fd-b2da-0943d3f7104d
    Distribution End Date
    2016-12-09

    Device Description

    Only GL GoodLife Blood Glucose Meter. No GCS in package, Economy type

    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

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

    GMDN Terms

    Code Name
    62537 Glucose monitoring system IVD, home-use

    Identifiers

    Type ID
    Package 00389154000624
    Primary 00389154000617

    Premarket Submissions

    Submission Number Supplement Number
    K113307 000