BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LEAF™

    DI: 05000223499891 · Model: 66802118 · SMITH & NEPHEW MEDICAL LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    LEAF™
    Primary DI
    05000223499891
    Version / Model
    66802118
    Catalog Number
    66802118
    Company Name
    SMITH & NEPHEW MEDICAL LIMITED
    Labeler DUNS
    216344051
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-02-22
    Public Version
    3
    Public Version Date
    2023-09-07
    Public Version Status
    Update
    Public Device Record Key
    3d3b9521-2ecb-47ed-be06-4c1a21532cfd

    Device Description

    Capital equipment to support the Leaf sensor patient montitoring system

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KMI Monitor, Bed Patient

    GMDN Terms

    Code Name
    65832 Wireless patient monitor/sensor reporting software, professional-only

    Identifiers

    Type ID
    Primary 05000223499891