BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Regard™

    DI: 30326053102784 · Model: 241028 · RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Regard™
    Primary DI
    30326053102784
    Version / Model
    241028
    Catalog Number
    241028
    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
    2023-07-28
    Public Version
    1
    Public Version Date
    2023-08-07
    Public Version Status
    New
    Public Device Record Key
    4b4bd8f7-a7f4-4cf5-aedb-7dc588b2ca59

    Device Description

    Insufflation Tubing Set, 10ft, high flow, ULPA 0.1 micron filter swivel luer & swivel luer

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NKC Tubing/Tubing With Filter, Insufflation, Laparoscopic

    GMDN Terms

    Code Name
    60738 Endoscopic insufflation tubing set, single-use

    Identifiers

    Type ID
    Package 20326053102787
    Primary 30326053102784
    Package 10326053102780