BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Glucology

    DI: 09352945004409 · Model: Libre Guardian CGM Patches - Planets · IBD MEDICAL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Glucology
    Primary DI
    09352945004409
    Version / Model
    Libre Guardian CGM Patches - Planets
    Company Name
    IBD MEDICAL
    Labeler DUNS
    747092954
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-02-02
    Public Version
    3
    Public Version Date
    2026-04-13
    Public Version Status
    Update
    Public Device Record Key
    49f56b33-bdd6-431b-92f8-d38bdfedba89

    Device Description

    Adhesive Sensor Patch

    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
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    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
    KGX Tape And Bandage, Adhesive

    GMDN Terms

    Code Name
    61069 Cable/lead/sensor non-conductive skin-adherent patch, single-use

    Identifiers

    Type ID
    Primary 09352945004409