BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    N/A

    DI: 00850022357299 · Model: XE-109 · Medi/Nuclear Corporation, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    N/A
    Primary DI
    00850022357299
    Version / Model
    XE-109
    Company Name
    Medi/Nuclear Corporation, Inc.
    Labeler DUNS
    079628327
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-11-09
    Public Version
    1
    Public Version Date
    2020-11-17
    Public Version Status
    New
    Public Device Record Key
    91836be2-bdcd-4dc6-8cad-add225dca027

    Device Description

    Bag, Equilibrium 5 Liter, for Upper Compartment for Xenon Administration System

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    IYT System, Rebreathing, Radionuclide

    GMDN Terms

    Code Name
    40907 Xenon administration system, diagnostic x-ray/CT

    Identifiers

    Type ID
    Primary 00850022357299

    Customer Contacts

    Phone
    800-321-5981
    Email
    [email protected]

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    store at room temperature