BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Trucise® 2.0 Total System

    DI: 05020583300088 · Model: METCM2 · TERUMO BCT, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Trucise® 2.0 Total System
    Primary DI
    05020583300088
    Version / Model
    METCM2
    Company Name
    TERUMO BCT, INC.
    Labeler DUNS
    801679200
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-15
    Public Version
    7
    Public Version Date
    2023-07-24
    Public Version Status
    Update
    Public Device Record Key
    cdd3d404-8778-4b7f-87a6-da576b420d97

    Device Description

    Trucise 2.0 Communication Module

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KSB SET, TRANSFER (BLOOD/PLASMA)

    GMDN Terms

    Code Name
    36149 Blood bank information system

    Identifiers

    Type ID
    Primary 05020583300088

    Customer Contacts

    Phone
    +1(877)339-4228
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    BK110071 0

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -10 – 50 Degrees Celsius