BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Malibu Aspiration Catheter System

    DI: 00850041053035 · Model: MALIBU12A-001 · Innova Vascular, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Malibu Aspiration Catheter System
    Primary DI
    00850041053035
    Version / Model
    MALIBU12A-001
    Company Name
    Innova Vascular, Inc.
    Labeler DUNS
    118406653
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-01-05
    Public Version
    1
    Public Version Date
    2024-01-15
    Public Version Status
    New
    Public Device Record Key
    e442cc3b-0fcf-4113-86f7-bc7aeb5276f5

    Device Description

    One (1) Malibu Aspiration Catheter System: Malibu Aspiration Catheter, Dilator, and Syringe

    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
    Labeling does not contain MRI Safety Information
    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
    No

    Product Codes

    Code Name
    QEW Peripheral Mechanical Thrombectomy With Aspiration
    KRA Catheter, Continuous Flush

    GMDN Terms

    Code Name
    66971 Thrombectomy suction catheterization kit

    Identifiers

    Type ID
    Primary 00850041053035