BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Dimension Vista® LIPID CAL

    DI: 00842768020452 · Model: 10464345 · Siemens Healthcare Diagnostics Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Dimension Vista® LIPID CAL
    Primary DI
    00842768020452
    Version / Model
    10464345
    Catalog Number
    KC220A
    Company Name
    Siemens Healthcare Diagnostics Inc.
    Labeler DUNS
    005088112
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    6
    Public Version Date
    2022-12-08
    Public Version Status
    Update
    Public Device Record Key
    89dd493a-1f5e-4355-95c9-56ecbf24e785

    Device Description

    Lipid Calibrator, 3x2x1.5mL

    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JIX CALIBRATOR, MULTI-ANALYTE MIXTURE

    GMDN Terms

    Code Name
    53356 Multiple lipid analyte IVD, calibrator

    Identifiers

    Type ID
    Primary 00842768020452

    Customer Contacts

    Phone
    +1(800)441-9250
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K061750 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    15 – 25 Degrees Celsius