BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    HELMED

    DI: 42601861205007 · Model: HELMED® IFA PROCESSOR KIT · Aesku.Systems GmbH & Co. KG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HELMED
    Primary DI
    42601861205007
    Version / Model
    HELMED® IFA PROCESSOR KIT
    Catalog Number
    HEL-1000
    Company Name
    Aesku.Systems GmbH & Co. KG
    Labeler DUNS
    341702675
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-27
    Public Version
    4
    Public Version Date
    2020-03-03
    Public Version Status
    Update
    Public Device Record Key
    0f47130b-99d9-42cc-8e21-9bf92d70892e
    Distribution End Date
    2020-03-02

    Device Description

    Automated IFA Processor

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JQW Station, Pipetting And Diluting, For Clinical Use

    GMDN Terms

    Code Name
    61927 Multi-modality clinical specimen analysis system IVD

    Identifiers

    Type ID
    Primary 42601861205007