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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Stradis Medical, LLC.

    DI: M752HCT2121CP10 · Model: HCT2121CP-1 · STRADIS MEDICAL LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Stradis Medical, LLC.
    Primary DI
    M752HCT2121CP10
    Version / Model
    HCT2121CP-1
    Company Name
    STRADIS MEDICAL LLC
    Labeler DUNS
    043537671
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-09
    Public Version
    3
    Public Version Date
    2022-06-17
    Public Version Status
    Update
    Public Device Record Key
    90050c9c-4e9d-4e20-a023-43d04704cb3e

    Device Description

    IV Start Kit

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    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
    LRS I.V. Start Kit

    GMDN Terms

    Code Name
    44057 General surgical procedure kit, medicated

    Identifiers

    Type ID
    Package M752HCT2121CP15
    Primary M752HCT2121CP10

    Customer Contacts

    Phone
    1-800-424-8520
    Email
    [email protected]