BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Dimension® CHEM I CAL

    DI: 00630414948492 · Model: 10716280 · Siemens Healthcare Diagnostics Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Dimension® CHEM I CAL
    Primary DI
    00630414948492
    Version / Model
    10716280
    Catalog Number
    DC18C
    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
    5
    Public Version Date
    2021-11-18
    Public Version Status
    Update
    Public Device Record Key
    45fe66e2-fbcc-4b04-b248-b1642b471a15

    Device Description

    Chemistry I Calibrator, 2x3x2mL

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    Yes
    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
    JJE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
    JIT CALIBRATOR, SECONDARY

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 00630414948492

    Customer Contacts

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

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius