BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    A-dec

    DI: 10194665001339 · Model: 90.1064.01 · A-DEC, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    A-dec
    Primary DI
    10194665001339
    Version / Model
    90.1064.01
    Catalog Number
    90.1064.01
    Company Name
    A-DEC, INC.
    Labeler DUNS
    009617473
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-10-27
    Public Version
    2
    Public Version Date
    2023-04-04
    Public Version Status
    Update
    Public Device Record Key
    2e064ad6-c115-4932-945e-aba573ad3476

    Device Description

    ICX Tablet,0.7 Liter,50 Count

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LRJ Disinfectant, Medical Devices

    GMDN Terms

    Code Name
    47631 Medical device disinfection agent

    Identifiers

    Type ID
    Package 20194665001336
    Primary 10194665001339

    Premarket Submissions

    Submission Number Supplement Number
    K051657 000