BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    E-Sphyg™ 3

    DI: 00634782097202 · Model: 9003W · AMERICAN DIAGNOSTIC CORP
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    E-Sphyg™ 3
    Primary DI
    00634782097202
    Version / Model
    9003W
    Catalog Number
    9003W
    Company Name
    AMERICAN DIAGNOSTIC CORP
    Labeler DUNS
    108999095
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-12-20
    Public Version
    1
    Public Version Date
    2019-12-30
    Public Version Status
    New
    Public Device Record Key
    93fcd886-4fef-4e3d-8978-b0e3cdcb4ea9

    Device Description

    Wall Mount w/Basket, E-sphyg 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
    Yes
    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DXN System, Measurement, Blood-Pressure, Non-Invasive

    GMDN Terms

    Code Name
    16173 Automatic-inflation electronic sphygmomanometer, non-portable

    Identifiers

    Type ID
    Primary 00634782097202

    Customer Contacts

    Phone
    1-800-232-2670
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Humidity
    Temperature Range
    15 – 90 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    -4 – 131 Degrees Fahrenheit