BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    GLUCOSE TEST STRIP 50 CT.

    DI: 00850578007044 · Model: GLUCOSE TEST STRIP 50 CT. · HEPRO.US INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    50

    Basic Information

    Brand Name
    GLUCOSE TEST STRIP 50 CT.
    Primary DI
    00850578007044
    Version / Model
    GLUCOSE TEST STRIP 50 CT.
    Company Name
    HEPRO.US INC.
    Labeler DUNS
    080061451
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    50
    Record Status
    Published
    Publish Date
    2017-06-20
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    81328e01-9880-44d7-86d6-4d22685fa1f6

    Device Description

    HEPRO.US GLUCOSE TEST STRIPS 50units/BX for MM1000

    Device Characteristics

    Single Use
    Yes
    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
    MR Safe
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    Yes

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

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

    GMDN Terms

    Code Name
    61913 Glucose/haematocrit monitoring system IVD, home-use

    Identifiers

    Type ID
    Primary 00850578007044
    Unit of Use 85057800704401