BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Regard™

    DI: 10326053100113 · Model: HT0013 · RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Regard™
    Primary DI
    10326053100113
    Version / Model
    HT0013
    Company Name
    RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
    Labeler DUNS
    945020902
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-12-20
    Public Version
    3
    Public Version Date
    2020-08-26
    Public Version Status
    Update
    Public Device Record Key
    148fb4a2-ae68-4a86-9056-730a1a76e0a6
    Distribution End Date
    2020-08-25

    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
    No
    MRI Safety
    MR Safe
    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
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OES Cardiac Catheterization Kit

    GMDN Terms

    Code Name
    46362 Fluid/device delivery cardiac catheter

    Identifiers

    Type ID
    Package 20326053100110
    Primary 10326053100113