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    FDA UDI In Commercial Distribution 🇺🇸 United States

    ADVIA Chemistry Systems 70-mL Wedges - Yellow

    DI: 00630414168258 · Model: 11223140 · Siemens Healthcare Diagnostics Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ADVIA Chemistry Systems 70-mL Wedges - Yellow
    Primary DI
    00630414168258
    Version / Model
    11223140
    Catalog Number
    11223140
    Company Name
    Siemens Healthcare Diagnostics Inc.
    Labeler DUNS
    064608573
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-04-30
    Public Version
    1
    Public Version Date
    2022-05-09
    Public Version Status
    New
    Public Device Record Key
    df48e85d-3b7d-4b23-abd4-b3602ce44ffa

    Device Description

    ADVIA Chemistry Systems 70-mL Wedges –Yellow

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    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
    JJE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

    GMDN Terms

    Code Name
    62225 Assay container IVD, single-use

    Identifiers

    Type ID
    Primary 00630414168258

    Customer Contacts

    Phone
    +1(877)229-3711
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K990346 000