BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Piccolo Medical

    DI: 00860002238586 · Model: FGS-15-852 · Piccolo Medical, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

    Basic Information

    Brand Name
    Piccolo Medical
    Primary DI
    00860002238586
    Version / Model
    FGS-15-852
    Catalog Number
    FGS-15-852
    Company Name
    Piccolo Medical, Inc.
    Labeler DUNS
    116996235
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2025-11-07
    Public Version
    1
    Public Version Date
    2025-11-17
    Public Version Status
    New
    Public Device Record Key
    0ad7007d-93e0-4ac7-9973-ab96a3091d44

    Device Description

    ECGuide Bundle Pack (10-pack)

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Radiation Sterilization

    Product Codes

    Code Name
    LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
    DRX Electrode, Electrocardiograph

    GMDN Terms

    Code Name
    61729 Central venous catheter navigation system support kit

    Identifiers

    Type ID
    Unit of Use 00860002238579
    Primary 00860002238586

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    10 – 40 Degrees Celsius