BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Beckman Coulter PK TP System Control Set

    DI: 00850212007041 · Model: PH3502 · FUJIREBIO DIAGNOSTICS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Beckman Coulter PK TP System Control Set
    Primary DI
    00850212007041
    Version / Model
    PH3502
    Company Name
    FUJIREBIO DIAGNOSTICS, INC.
    Labeler DUNS
    079291908
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-16
    Public Version
    5
    Public Version Date
    2023-08-21
    Public Version Status
    Update
    Public Device Record Key
    653781ec-764b-468e-8068-f780fcf4af6d

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    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
    KSF Kit, Quality Control For Blood Banking Reagents

    GMDN Terms

    Code Name
    37733 Treponema pallidum total antibody IVD, control

    Identifiers

    Type ID
    Primary 00850212007041

    Customer Contacts

    Phone
    800-447-5852
    Email
    [email protected]
    Phone
    800-223-0125
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    BK060062 0
    BK960070 0

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify Size Type = Units per Kit; Units = 16; Units of Measure = 5mLs

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    2 – 30 Degrees Celsius
    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius