BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TRANSMEDICS, INC.

    Reg #: 3003152463 · FEI: 3003152463 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    TRANSMEDICS, INC.
    Registration Number
    3003152463
    FEI Number
    3003152463
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    200 MINUTEMAN RD STE 302
    City
    Andover
    State
    MA
    ZIP
    01810
    Country
    US

    Regulatory Submissions

    510(k) Number
    K211314
    PMA Number
    P160013

    Owner / Operator

    Firm Name
    TransMedics
    Operator Number
    10045349
    Address
    200 Minuteman Road, Suite 302
    City
    Andover
    State
    MA
    Postal Code
    01810
    Country
    US
    Correspondent
    Christy Foreman

    Products

    Device Name Product Code
    Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs PHO
    Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation QBA
    System And Accessories, Isolated Heart, Transport And Preservation MSB
    Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation QQK
    Filter, Blood, Cardiopulmonary Bypass, Arterial Line DTM
    Organ Care System (Ocs) Heart System QIK

    Proprietary Names

    OCS Lung System OCS Lung Solution OCS Liver OCS Lung Donor Flush Set Organ Care System (OCS) Heart

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility