BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Status DS™ controls

    DI: 10743816001546 · Model: 21000 · PRINCETON BIOMEDITECH CORPORATION
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Status DS™ controls
    Primary DI
    10743816001546
    Version / Model
    21000
    Company Name
    PRINCETON BIOMEDITECH CORPORATION
    Labeler DUNS
    362917692
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-10-20
    Public Version
    1
    Public Version Date
    2020-10-28
    Public Version Status
    New
    Public Device Record Key
    a03febe9-9685-41d5-b4b5-672df07b35e3

    Device Description

    Status DS Control Set (Neg&Pos 2.5 ml)

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    Yes
    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

    GMDN Terms

    Code Name
    55461 Multiple drugs of abuse IVD, control

    Identifiers

    Type ID
    Primary 10743816001546

    Customer Contacts

    Phone
    800-526-2125
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius