BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ZOLL Circulation, Inc.

    Reg #: 3010617000 · FEI: 3003793491 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    43
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    ZOLL Circulation, Inc.
    Registration Number
    3010617000
    FEI Number
    3003793491
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2000 Ringwood Ave
    City
    San Jose
    State
    CA
    ZIP
    95131
    Country
    US

    Regulatory Submissions

    510(k) Number
    K072527
    PMA Number
    P170027

    Owner / Operator

    Firm Name
    ZOLL Medical Corporation
    Operator Number
    1220908
    Address
    269 MILL ROAD
    City
    Chelmsford
    State
    MA
    Postal Code
    01824
    Country
    US

    Products

    Device Name Product Code
    Compressor, Cardiac, External DRM
    System, Hypothermia, Intravenous, Cooling NCX
    System, Thermal Regulating DWJ
    Hyperthermia Monitor NZE
    System, Oxygen, Aqueous MWG
    Mattress, Water, Temperature Regulated FOH

    Proprietary Names

    Autopulse Resuscitation System Model 100 Icy Model Catheter Cool Line Catheter ICY Catheter, Quattro Catheter, Cool Line Catheter Thermogard XP Console Thermogard HQ Console Thermogard HQ Thermogard XP CoolGard 3000 Solex Intravascular Heat Exchange Catheter AutoPulse Recusitation System Model 100, AutoPulse Lithium-Ion Battery, AutoPulse Multi-Chemistry Battery Charger Start-Up Kit (SUK) ICY® Intravascular Heat Exchange Catheter Quattro™ Intravascular Heat Exchange Catheter Solex Catheter ICY Intravascular Heat Exchange Catheter Coolgard 3000 Console Cool Line Intravascular Heat Exchange Catheter Solex 7 Intravascular Heat Exchange Catheter Quattro Intravascular Heat Exchange Catheter Start-Up Kit Thermogard Vest S/M Thermogard XP Temperature Management System Thermogard Surface System Surface Start-Up Kits Surface Temperature Management System Thermogard XP Refurbished STx Vest L/XL Thermogard HQ Refurbished STx Surface Pads Thermogard HQ Temperature Management System Thermogard HQ Surface Start-Up Kit (TGHQ-SURF) STx Vest S/M Thermogard Vest L/XL STx Surface Pad Surface Start-Up Kit (CG-SURF) TherOx SSO2 Catheter TherOx DownStream Console TherOx DownStream Cartridge TherOx DownStream Console, Refurbished AutoPulse Resuscitation System Mode Quattro Catheter InnerCool STx+ Surface Pads Set

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device