BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    GEM Premier 3500

    DI: 08426950793328 · Model: 00026000000 · INSTRUMENTATION LABORATORY COMPANY
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    GEM Premier 3500
    Primary DI
    08426950793328
    Version / Model
    00026000000
    Catalog Number
    00026000000
    Company Name
    INSTRUMENTATION LABORATORY COMPANY
    Labeler DUNS
    557223252
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    6
    Public Version Date
    2022-09-16
    Public Version Status
    Update
    Public Device Record Key
    7641ca39-f491-4062-93ee-9503e014d56c

    Device Description

    GEM Premier 3500

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    CHL ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH

    GMDN Terms

    Code Name
    56663 Blood gas/haemoximetry analyser IVD, laboratory

    Identifiers

    Type ID
    Primary 08426950793328

    Customer Contacts

    Phone
    1-800-678-0710
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    15 – 25 Degrees Celsius