BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Spaulding Client App

    DI: B441SMANDCLIENTAPP0 · Model: 1.2.6.1 · SPAULDING MEDICAL, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Spaulding Client App
    Primary DI
    B441SMANDCLIENTAPP0
    Version / Model
    1.2.6.1
    Catalog Number
    SMANDCLIENTAPP
    Company Name
    SPAULDING MEDICAL, LLC
    Labeler DUNS
    116813644
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-04-02
    Public Version
    2
    Public Version Date
    2026-01-30
    Public Version Status
    Update
    Public Device Record Key
    b3d5700a-3fd4-4e8b-8e28-eb3664b60d7a

    Device Description

    Spaulding Client Application is a web based application for trained users of the Spaulding Medical Electrocardiograph device 2100iQ. The application enables clinicians or trained core personnel who are acting on the orders of a licensed physician to process, display, store, and print diagnostic 12 lead ECGs utilizing an Android platform.

    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
    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
    PYT Device, Fertility Diagnostic, Contraceptive, Software Application

    GMDN Terms

    Code Name
    41651 Electrocardiographic long-term ambulatory recording analyser application software

    Identifiers

    Type ID
    Primary B441SMANDCLIENTAPP0