BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Evotech

    DI: 10705037048465 · Model: 907501 · ADVANCED STERILIZATION PRODUCTS SERVICES INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Evotech
    Primary DI
    10705037048465
    Version / Model
    907501
    Catalog Number
    907501
    Company Name
    ADVANCED STERILIZATION PRODUCTS SERVICES INC.
    Labeler DUNS
    947451626
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    5
    Public Version Date
    2023-08-16
    Public Version Status
    Update
    Public Device Record Key
    81eadc79-504e-4ab7-936a-9af5b81a7ea9

    Device Description

    Channel Connector Tube

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FEB ACCESSORIES, CLEANING, FOR ENDOSCOPE

    GMDN Terms

    Code Name
    64640 Endoscope channel-opening adaptor

    Identifiers

    Type ID
    Primary 10705037048465

    Customer Contacts

    Phone
    +1(888)783-7723
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K082392 000
    K140977 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    15 – 30 Degrees Celsius