BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Welch Allyn, Inc.

    DI: 00732094202090 · Model: 901012 · 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
    00732094202090
    Version / Model
    901012
    Catalog Number
    105611
    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
    3
    Public Version Date
    2021-11-10
    Public Version Status
    Update
    Public Device Record Key
    168aced1-7209-4b5a-bc35-a88461412ae3

    Device Description

    SERV KIT CVSM ES MODULE W Bed SENSOR

    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
    Yes
    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
    DRT MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)

    GMDN Terms

    Code Name
    36872 Multiple vital physiological parameter monitoring system, clinical

    Identifiers

    Type ID
    Primary 00732094202090

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K951246 000