BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Regard™

    DI: 10194717117865 · Model: AN01238A · ROI CPS, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Regard™
    Primary DI
    10194717117865
    Version / Model
    AN01238A
    Company Name
    ROI CPS, LLC
    Labeler DUNS
    117174678
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-11-09
    Public Version
    1
    Public Version Date
    2023-11-17
    Public Version Status
    New
    Public Device Record Key
    5b9aef67-c7c7-4539-842a-dcb20a2615dd

    Device Description

    IV START BLOOD COLLECTION 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
    OIB Blood And Urine Collection Kit (Excludes Hiv Testing)

    GMDN Terms

    Code Name
    33961 General surgical procedure kit, non-medicated, single-use

    Identifiers

    Type ID
    Package 20194717117862
    Primary 10194717117865