BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LifeSPARC

    DI: 00814112020562 · Model: 5900-0000 · CARDIACASSIST, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    LifeSPARC
    Primary DI
    00814112020562
    Version / Model
    5900-0000
    Company Name
    CARDIACASSIST, INC.
    Labeler DUNS
    948683941
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-12-18
    Public Version
    2
    Public Version Date
    2023-02-01
    Public Version Status
    Update
    Public Device Record Key
    87dc4a70-f0ee-4da3-95bb-a51a653fbce9

    Device Description

    Blood pump controller, charging station, Power cord, flow sensor, removable batteries

    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
    DWA Control, Pump Speed, Cardiopulmonary Bypass
    QNR Blood Pump For Ecmo, Long-Term (> 6 Hours) Use

    GMDN Terms

    Code Name
    33317 Cardiopulmonary bypass system centrifugal pump drive unit

    Identifiers

    Type ID
    Primary 00814112020562

    Customer Contacts

    Phone
    18003737421
    Email
    [email protected]
    Phone
    +14129637770
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K183623 000
    K211830 000