BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Blue2 4th Generation

    DI: 00186648000609 · Model: 10000033 · Ablenet, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Blue2 4th Generation
    Primary DI
    00186648000609
    Version / Model
    10000033
    Catalog Number
    10000033
    Company Name
    Ablenet, Inc.
    Labeler DUNS
    791664543
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-23
    Public Version
    1
    Public Version Date
    2023-07-03
    Public Version Status
    New
    Public Device Record Key
    092f44bd-e34b-4f79-aad0-7a19a1cae0b5

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KNO Accessories, Wheelchair

    GMDN Terms

    Code Name
    65892 Assistive human interface device proximal control, hand-operated

    Identifiers

    Type ID
    Primary 00186648000609