BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    FLIGHT MEDICAL INNOVATIONS LTD.

    Reg #: 3003135857 · FEI: 3003135857 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    27
    Establishment Types
    5
    Classifications
    9

    Registration Details

    Registration Name
    FLIGHT MEDICAL INNOVATIONS LTD.
    Registration Number
    3003135857
    FEI Number
    3003135857
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    7 HATNUFA ST.
    City
    PETACH TIKVA Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K223120

    Owner / Operator

    Firm Name
    Flight Medical Innovations Ltd
    Operator Number
    9046407
    Address
    7 Hatnufa St.
    City
    Petach Tikva
    State
    IL-NOTA
    Postal Code
    4951025
    Country
    IL

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Ventilator, Continuous, Facility Use CBK
    Bag, Reservoir BTC
    Portable Liquid Oxygen Unit Stand PCM
    Set, Tubing And Support, Ventilator (W Harness) BZO
    Cart, Emergency, Cardiopulmonary (Excluding Equipment) BZN
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    Support, Breathing Tube JAY
    Continuous, Ventilator, Home Use NOU
    Container, Specimen, Non-Sterile NNI

    Proprietary Names

    Nerport HT50 Test Lung Kit O2 Kit F60/VX Quick Release Kit F60 Quick Release Kit F60 Rail Mount Kit Roll Stand for use with ventilators Ventoux Ventilator 3 Section Arm with Ex FLIGHT60 F60 DL Ped Flow Sensor Kit F60 DL Flow Sensor Kit F60 DL Single Use PC F60 DL Single Use Ped PC F60 Ped DL Flow Sensor Kit RD F60 SL Ped SU PC RD F60 SL Single Use Ped PC F60 Ped. SL FS Kit RD F60 SL Flow Sensor Kit F60 SL Single Use PC F60 DL Ped Single Use PC RD F60 SL ped. Flow Sensor Kit Flight 60 In use Carrying Case HT50 Dual Pac Flight 60 Flight60 Flight 60T

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198