BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ARCHITECT

    DI: 00380740000394 · Model: 1E49-20 · ABBOTT LABORATORIES
    View on AccessGUDID
    Product Codes
    4
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ARCHITECT
    Primary DI
    00380740000394
    Version / Model
    1E49-20
    Catalog Number
    01E4920
    Company Name
    ABBOTT LABORATORIES
    Labeler DUNS
    079226220
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-06-06
    Public Version
    3
    Public Version Date
    2020-12-21
    Public Version Status
    Update
    Public Device Record Key
    02746006-a597-4f56-80f8-57d5815ec2b4

    Device Description

    ICT Reference Solution

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
    JGS ELECTRODE, ION SPECIFIC, SODIUM
    CEM ELECTRODE, ION SPECIFIC, POTASSIUM
    JJE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

    GMDN Terms

    Code Name
    47868 Multiple-type clinical chemistry analyte profile IVD, calibrator

    Identifiers

    Type ID
    Primary 00380740000394

    Customer Contacts

    Phone
    +1(877)422-2688
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    15 – 30 Degrees Celsius