BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Anivia SG1000 Pump Console - Pump Driver Module

    Reg #: 3015431638 · FEI: 3015431638 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    APMTD, INC.
    Registration Number
    3015431638
    FEI Number
    3015431638
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    226 Lowell Street, Unit B16
    City
    Wilmington
    State
    MA
    ZIP
    01887
    Country
    US

    Regulatory Submissions

    510(k) Number
    K221491

    Owner / Operator

    Firm Name
    APMTD, Inc.
    Operator Number
    10060044
    Address
    226 Lowell St, Unit B16
    City
    Wilmington
    State
    MA
    Postal Code
    01887
    Country
    US
    Correspondent
    John Sasso

    Products

    Device Name Product Code
    Control, Pump Speed, Cardiopulmonary Bypass DWA

    Proprietary Names

    Anivia SG1000 Pump Console - Pump Driver Module Anivia SG1000 Pump Console - Flow Bubble Sensor Anivia SG1000 Pump Console - Display and Control Module Anivia SG1000 Pump Console Anivia SG1000 Pump Console - Backup Battery Module Anivia SG1000 Pump Console - Cart Module

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198