BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    BLE Smart Test Strip

    DI: 10852668007016 · Model: BLE-SMART-TS50-FDA · ENTRA HEALTH SYSTEMS LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BLE Smart Test Strip
    Primary DI
    10852668007016
    Version / Model
    BLE-SMART-TS50-FDA
    Company Name
    ENTRA HEALTH SYSTEMS LLC
    Labeler DUNS
    826314044
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-02-05
    Public Version
    2
    Public Version Date
    2021-10-28
    Public Version Status
    Update
    Public Device Record Key
    061cb1b2-5820-476b-b14d-6ba59517ca2a
    Distribution End Date
    2020-04-01

    Device Description

    BLE Smart Test Strip Vial

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LFR Glucose Dehydrogenase, Glucose

    GMDN Terms

    Code Name
    53303 Glucose IVD, kit, electrometry

    Identifiers

    Type ID
    Primary 10852668007016

    Storage Conditions

    Type
    Storage Environment Humidity
    Temperature Range
    10 – 85 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    36 – 86 Degrees Fahrenheit