BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Regard™

    DI: 00326053116087 · Model: 370003 · 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
    00326053116087
    Version / Model
    370003
    Catalog Number
    370003REG
    Company Name
    RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
    Labeler DUNS
    134472476
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-10-30
    Public Version
    5
    Public Version Date
    2023-01-04
    Public Version Status
    Update
    Public Device Record Key
    9adff94b-e7b1-45ba-b433-5b934576114c

    Device Description

    IJ KIT

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Unsafe
    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
    PEZ Central Venous Catheter Dressing Change Kit

    GMDN Terms

    Code Name
    61345 Arterial/central venous catheterization support/maintenance kit, non-medicated

    Identifiers

    Type ID
    Package 10326053116084
    Primary 00326053116087