BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AeroPace Neurostimulation Catheter Kit

    DI: 00810073210004 · Model: 000-0036 · Lungpacer Medical USA Inc.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AeroPace Neurostimulation Catheter Kit
    Primary DI
    00810073210004
    Version / Model
    000-0036
    Company Name
    Lungpacer Medical USA Inc.
    Labeler DUNS
    080998049
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-03-10
    Public Version
    1
    Public Version Date
    2025-03-18
    Public Version Status
    New
    Public Device Record Key
    f5eb23a7-e169-46e9-9266-385eb46ecc94

    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 Conditional
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    GMDN Terms

    Code Name
    62679 Transvenous phrenic nerve electrical stimulation control unit

    Identifiers

    Type ID
    Primary 00810073210004