BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SmartHeart

    DI: 00845717006811 · Model: 11-50L · VERIDIAN HEALTHCARE LLC
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SmartHeart
    Primary DI
    00845717006811
    Version / Model
    11-50L
    Catalog Number
    11-50L
    Company Name
    VERIDIAN HEALTHCARE LLC
    Labeler DUNS
    830437997
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-05-02
    Public Version
    3
    Public Version Date
    2023-04-26
    Public Version Status
    Update
    Public Device Record Key
    4ce0e390-14c4-453f-ae70-d7db42f0dc2f

    Device Description

    SmartHeart Talking Pulse Oximeter

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DQA Oximeter
    OCH Oximeter, Infrared, Sporting, Aviation

    GMDN Terms

    Code Name
    37808 Pulse oximeter probe, reusable

    Identifiers

    Type ID
    Package 10845717006818
    Package 30845717006812
    Primary 00845717006811

    Customer Contacts

    Phone
    866-326-1313
    Email
    [email protected]