BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    RegenKit®-THT-1-U

    DI: 00850033131208 · Model: RK-THT-1-U · Regenlab USA LLC
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    RegenKit®-THT-1-U
    Primary DI
    00850033131208
    Version / Model
    RK-THT-1-U
    Company Name
    Regenlab USA LLC
    Labeler DUNS
    087434117
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-03-23
    Public Version
    1
    Public Version Date
    2026-03-31
    Public Version Status
    New
    Public Device Record Key
    9a4cc680-acd0-4125-8b6c-239e0e3dff1a

    Device Description

    Single pack of one THT tube labeled as RegenKit-THT-1. Made in USA identified as -U

    Device Characteristics

    Single Use
    Yes
    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FMI Needle, Hypodermic, Single Lumen
    FMF Syringe, Piston

    GMDN Terms

    Code Name
    46923 Haematological concentrate system preparation kit, platelet concentration

    Identifiers

    Type ID
    Primary 00850033131208

    Premarket Submissions

    Submission Number Supplement Number
    BK090048 0

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    5 – 30 Degrees Celsius