BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Welch Allyn, Inc.

    DI: 00817655021294 · Model: 901144 · WELCH ALLYN, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Welch Allyn, Inc.
    Primary DI
    00817655021294
    Version / Model
    901144
    Catalog Number
    419770
    Company Name
    WELCH ALLYN, INC.
    Labeler DUNS
    198227881
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-02-18
    Public Version
    2
    Public Version Date
    2020-12-18
    Public Version Status
    Update
    Public Device Record Key
    b02ea72d-359a-484f-8882-d5da1a2942e2
    Distribution End Date
    2020-12-17

    Device Description

    DVD SOFTWARE XScribe CP v4.0.3

    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
    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
    DPS Electrocardiograph

    GMDN Terms

    Code Name
    35562 Electrocardiographic lead set, reusable

    Identifiers

    Type ID
    Primary 00817655021294

    Customer Contacts

    Phone
    +1(315)685-2834
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K152944 000