BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Regard™

    DI: 10194717119074 · Model: LD01114F · ROI CPS, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Regard™
    Primary DI
    10194717119074
    Version / Model
    LD01114F
    Company Name
    ROI CPS, LLC
    Labeler DUNS
    117174678
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-03-25
    Public Version
    2
    Public Version Date
    2025-04-16
    Public Version Status
    Update
    Public Device Record Key
    66a9b3eb-1ed5-4416-a2ee-ba84762c76a0
    Distribution End Date
    2025-04-15

    Device Description

    NEWBORN 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
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    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
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MLS Labor And Delivery Kit

    GMDN Terms

    Code Name
    34988 Birthing/delivery kit

    Identifiers

    Type ID
    Package 20194717119071
    Primary 10194717119074