BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BUTTERFLY iQ+

    DI: 00866646000213 · Model: 850-20014 · BUTTERFLY NETWORK, INC.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BUTTERFLY iQ+
    Primary DI
    00866646000213
    Version / Model
    850-20014
    Company Name
    BUTTERFLY NETWORK, INC.
    Labeler DUNS
    064617010
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-29
    Public Version
    1
    Public Version Date
    2020-10-07
    Public Version Status
    New
    Public Device Record Key
    af7bdee3-d2fe-4675-a521-7eb5ec878294

    Device Description

    BUTTERFLY iQ+

    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
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IYN System, imaging, pulsed doppler, ultrasonic
    IYO System, imaging, pulsed echo, ultrasonic
    ITX Transducer, ultrasonic, diagnostic

    GMDN Terms

    Code Name
    60924 Hand-held ultrasound imaging system, body-surface

    Identifiers

    Type ID
    Primary 00866646000213

    Customer Contacts

    Phone
    +1(855)296-6188
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K163510 000