BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Welch Allyn, Inc.

    DI: 00732094035261 · Model: 901006 · 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
    00732094035261
    Version / Model
    901006
    Catalog Number
    008-0322-01
    Company Name
    WELCH ALLYN, INC.
    Labeler DUNS
    198227881
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-01-16
    Public Version
    1
    Public Version Date
    2020-01-24
    Public Version Status
    New
    Public Device Record Key
    a93d2e9d-5bd7-4b97-bc75-a2b1ec1c78b3

    Device Description

    ECG, 5-Lead Wire Set, safety DIN .060, snap for use with 008-0314-01 (IEC)

    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
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MLD MONITOR, ST SEGMENT WITH ALARM

    GMDN Terms

    Code Name
    35562 Electrocardiographic lead set, reusable

    Identifiers

    Type ID
    Primary 00732094035261

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K972121 000