BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HeartWare® Controller DC Adapter

    DI: 00888707000109 · Model: 1435 · Heartware Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HeartWare® Controller DC Adapter
    Primary DI
    00888707000109
    Version / Model
    1435
    Catalog Number
    1435
    Company Name
    Heartware Inc.
    Labeler DUNS
    146054536
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2014-08-14
    Public Version
    3
    Public Version Date
    2023-04-20
    Public Version Status
    Update
    Public Device Record Key
    109fd444-c9e1-4d7d-bcc2-aa72e26c0c1e

    Device Characteristics

    Single Use
    Yes
    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
    DSQ Ventricular (Assisst) Bypass

    GMDN Terms

    Code Name
    16977 Artificial heart, temporary

    Identifiers

    Type ID
    Primary 00888707000109