BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Dimension Vista® Testosterone Calibrator

    DI: 00630414948775 · Model: 10712611 · Siemens Healthcare Diagnostics Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Dimension Vista® Testosterone Calibrator
    Primary DI
    00630414948775
    Version / Model
    10712611
    Catalog Number
    KC638
    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
    2023-05-03
    Public Version Status
    Update
    Public Device Record Key
    36b7294c-8e8d-4c49-8206-3ff7e50bdfab

    Device Description

    Testosterone Calibrator, 12 (2A x 1.0 mL; 2B x 1.0 mL; 2C x 1.0 mL; 2D x 1.0 mL; 2E x 1.0 mL; 2F x 1.0 mL)

    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
    JIT CALIBRATOR, SECONDARY

    GMDN Terms

    Code Name
    58381 Total testosterone IVD, calibrator

    Identifiers

    Type ID
    Primary 00630414948775

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K151529 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius