BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Vave

    DI: 00850001977050 · Model: VA-0175 · Vave Health, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Vave
    Primary DI
    00850001977050
    Version / Model
    VA-0175
    Catalog Number
    VA-0175
    Company Name
    Vave Health, Inc.
    Labeler DUNS
    084088994
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-06-14
    Public Version
    1
    Public Version Date
    2021-06-22
    Public Version Status
    New
    Public Device Record Key
    e6369ad0-94a0-480e-b635-84cb48d8c957

    Device Description

    BATTERY ASSEMBLY COMPLETE (rev A)

    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ITX Transducer, Ultrasonic, Diagnostic
    IYO System, Imaging, Pulsed Echo, Ultrasonic

    GMDN Terms

    Code Name
    32033 Battery box

    Identifiers

    Type ID
    Primary 00850001977050

    Customer Contacts

    Phone
    877-828-3435
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K191541 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -40 – 35 Degrees Celsius
    Type
    Storage Environment Humidity
    Temperature Range
    15 – 90 Percent (%) Relative Humidity
    Type
    Storage Environment Atmospheric Pressure
    Temperature Range
    620 – 1060 KiloPascal
    Type
    Handling Environment Temperature
    Temperature Range
    0 – 40 Degrees Celsius
    Type
    Handling Environment Humidity
    Temperature Range
    15 – 90 Percent (%) Relative Humidity
    Type
    Handling Environment Atmospheric Pressure
    Temperature Range
    620 – 1060 KiloPascal