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    FDA UDI In Commercial Distribution 🇺🇸 United States

    ProC Control Plasma

    DI: 00630414640624 · Model: 10873865 · Siemens Healthcare Diagnostics Products GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    6

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    Basic Information

    Brand Name
    ProC Control Plasma
    Primary DI
    00630414640624
    Version / Model
    10873865
    Catalog Number
    10873865
    Company Name
    Siemens Healthcare Diagnostics Products GmbH
    Labeler DUNS
    388240673
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    6
    Record Status
    Published
    Publish Date
    2024-03-25
    Public Version
    1
    Public Version Date
    2024-04-02
    Public Version Status
    New
    Public Device Record Key
    9b9a9903-da59-47c6-96db-73227f1e4fef

    Device Description

    Assayed control to monitor the performance of Factor V Leiden assay in the pathological range

    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
    GGN Plasma, coagulation control

    GMDN Terms

    Code Name
    47390 Protein C IVD, control

    Identifiers

    Type ID
    Unit of Use 00842768019005
    Primary 00630414640624

    Customer Contacts

    Phone
    +1(800)242-3233
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K042333 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius