BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ZOLL MEDICAL CORPORATION

    Reg #: 1220908 · FEI: 1220908 · Expires 2026
    View on FDA
    Products
    32
    Proprietary Names
    74
    Establishment Types
    4
    Classifications
    32

    Registration Details

    Registration Name
    ZOLL MEDICAL CORPORATION
    Registration Number
    1220908
    FEI Number
    1220908
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    269 MILL ROAD
    City
    CHELMSFORD
    State
    MA
    ZIP
    01824
    Country
    US

    Regulatory Submissions

    510(k) Number
    K083688
    PMA Number
    P890057

    Owner / Operator

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

    Products

    Device Name Product Code
    Ventilator, High Frequency LSZ
    Ventilator, Continuous, Facility Use CBK
    Electrode, Electrocardiograph DRX
    Cart, Emergency, Cardiopulmonary (Excluding Equipment) BZN
    Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve PIZ
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Continuous Measurement Thermometer FLL
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Electrocardiograph DPS
    Computer, Blood-Pressure DSK
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Oximeter DQA
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Pump, Infusion FRN
    Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) DRO
    Automated External Defibrillators (Non-Wearable) MKJ
    Dc-Defibrillator, Low-Energy, (Including Paddles) LDD
    Aid, Cardiopulmonary Resuscitation LIX
    Transducer, Gas Flow BXP
    Strap, Head, Gas Mask BTK
    Blood Pressure Cuff DXQ
    Display, Cathode-Ray Tube, Medical DXJ
    Pump, Portable, Aspiration (Manual Or Powered) BTA
    Stand, Infusion FOX
    Ventilator, Non-Continuous (Respirator) BZD
    Support, Breathing Tube JAY
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Spirometer, Therapeutic (Incentive) BWF
    Sleeve, Limb, Compressible JOW
    Kit, First Aid, Talking OVR
    Wearable Automated External Defibrillator MVK
    Battery, Replacement, Rechargeable MOQ

    Proprietary Names

    3100A High Frequency Oscillating Ventilator 3100B High Frequency Oscillating Ventilator LTV 1200 MR LTV 1100 Ventilator LTV2 LTV 2200 MRI Roll Stand Roll Stand ZOLL AUTOCLAVABLE EXTERNAL PADDLES ZOLL AUTOCLAVABLE INTERNAL HANDLES ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES LTV Series with Heated Breathing Circuit ACCUVENT SENSOR DISPOSABLE FLOWTUBE, ACCUVENT FLOW SENSOR CONNECTOR, ACCUVENT LTV 1200 Ventilator Neonate Cuff and Adapter Kit ZOLL ePCR iOS Eagle II AEV EMV+ Special Medical Emergency Evacuation Device (SMEED) INFANT FLOW LP NASAL MASKS, EXTRA LARGE INFANT FLOW LP, GENERATOR SET W/O PRONGS, 1EA INFANT FLOW LP NASAL PRONGS, MEDIUM INFANT FLOW LP NASAL PRONGS,EXTRA SMALL INFANT FLOW LP NASAL MASKS, LARGE INFANT FLOW LP, GENERATOR KIT W/RT132 CIRCUIT, 20PK Infant Flow LP System INFANT FLOW LP, GENERATOR KIT W/RT132 CIRCUIT, 10PK INFANT FLOW LP NASAL PRONGS, EXTRA LARGE INFANT FLOW LP, GENERATOR SET W/O PRONGS, 10PK INFANT FLOW LP, GENERATOR SET, 1 EA INFANT FLOW LP NASAL PRONGS, LARGE INFANT FLOW LP NASAL MASKS, MEDIUM INFANT FLOW LP NASAL MASKS, SMALL INFANT FLOW LP NASAL MASKS, EXTRA SMALL INFANT FLOW LP NASAL PRONGS, SMALL INFANT FLOW LP, GENERATOR SET, 10PK LTV Rolling Stand and Accessories Patient Circuit W/PEEP, 22mm, SPU Patient Circuit W/O PEEP, 22mm, SPU, Dual Heated Wire, F&P Patient Circuit W/O PEEP Patient Circuit W/O PEEP, 15mm, SPU, Dual Heated Wire, F&P LTV 1000 Ventilator 731 Series Z Vent ZOLL Code Writer INFANT FLOW LP NASAL PRONGS,SMALL INFANT FLOW LP NASAL MASKS,SMALL INFANT FLOW LP NASAL MASKS,LARGE INFANT FLOW LP NASAL MASKS,MEDIUM INFANT FLOW LP NASAL PRONGS,LARGE INFANT FLOW LP NASAL MASKS,EXTRA LRGE INFANT FLOW LP NASAL MASKS,EXTRA SMALL INFANT FLOW LP NASAL PRONGS,MEDIUM PACKAGE ASSEMBLY, GENERATOR WITHOUT PRONGS INFANT FLOW LP NASAL PRONGS,EXTRA LRGE PCKG ASSY GNRTR KIT W RT132 CIRCTS PACKAGE ASSEMBLY,GENERATOR KIT W/RT132 CIRCUITS PACKAGE ASSEMBLY, INFANT FLOW, LP Diagnostic Package Capnography – Sidestream Diagnostic Package Capnography – Mainstream bellavista 1000e Exhalation Valve Single Use bellavista 1000 Select Integrated Exhalation Valve iFlow 200S Adult/Pediatric Proximal Flow Sensors iFlow 40S Neonatal/Infant Proximal Flow Sensors bellavista 1000 Exhalation Valve Cassette Desktop Charger, LTV2, English Desktop Charger, LTV2, International Removable Battery, LTV2

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Repack or Relabel Medical Device