BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Regard™

    DI: 10326053118453 · Model: 405218REG · 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
    10326053118453
    Version / Model
    405218REG
    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
    2022-05-03
    Public Version
    2
    Public Version Date
    2022-06-17
    Public Version Status
    Update
    Public Device Record Key
    c1339731-87d4-4709-85ef-928422500da8

    Device Description

    IV START KIT-NON-SPLIT DRESSING 1.5ML CHLORAPREP

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    33961 General surgical procedure kit, non-medicated, single-use

    Identifiers

    Type ID
    Package 20326053118450
    Primary 10326053118453