BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Helix Elite™ Molecular Standards: Inactivated Standard

    DI: 10845357044409 · Model: HE0082HF · MICROBIOLOGICS INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Helix Elite™ Molecular Standards: Inactivated Standard
    Primary DI
    10845357044409
    Version / Model
    HE0082HF
    Catalog Number
    HE0082HF
    Company Name
    MICROBIOLOGICS INC.
    Labeler DUNS
    060467826
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-04-15
    Public Version
    1
    Public Version Date
    2026-04-23
    Public Version Status
    New
    Public Device Record Key
    d7dc1785-c4f7-4348-b338-17912ef48286

    Device Description

    HE0082HF GI Hydration Fluid

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PPM General Purpose Reagent

    GMDN Terms

    Code Name
    58673 Saline suspension medium/diluent IVD

    Identifiers

    Type ID
    Primary 10845357044409