BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ARCHITECT

    DI: 00380740163372 · Model: 1E49-21 · Abbott GmbH
    View on AccessGUDID
    Product Codes
    4
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ARCHITECT
    Primary DI
    00380740163372
    Version / Model
    1E49-21
    Catalog Number
    01E4921
    Company Name
    Abbott GmbH
    Labeler DUNS
    315786293
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-08-15
    Public Version
    2
    Public Version Date
    2020-10-13
    Public Version Status
    Update
    Public Device Record Key
    dd9e15e9-d1f4-4fe2-be48-7bf2387e8207

    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
    JJE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
    JGS ELECTRODE, ION SPECIFIC, SODIUM
    CEM ELECTRODE, ION SPECIFIC, POTASSIUM

    GMDN Terms

    Code Name
    59238 Ion selective electrode (ISE) reference solution IVD, reagent

    Identifiers

    Type ID
    Primary 00380740163372

    Customer Contacts

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

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    15 – 30 Degrees Celsius