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510(k) Data Aggregation

    K Number
    K232171
    Device Name
    Purema® H Hemoconcentrator (EtO Sterilized)
    Manufacturer
    Date Cleared
    2024-02-07

    (201 days)

    Product Code
    Regulation Number
    876.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tecnoideal America

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Purema® H Hemoconcentrator is designed to remove excess fluid from the blood in order to maintain proper hematocrit and protein concentration during cardiopulmonary bypass and to enable reinfusion of blood remaining in the circuit after bypass. It is intended to be used in a hospital setting, in connection with a suitable circuit for extracorporeal blood circulation and a pump that regulates its flow. There are no other accessories. The Purema® H Hemoconcentrator Models DP07HC, DP09HC, and DP12HC are intended to be used for adult patients.
    Device Description
    Purema® H hemoconcentrators are single use hemoconcentrators containing filters composed of a hollow fiber made of polyethersulfone (PUREMA® H). Purema® H hemoconcentrators are hemoconcentrators of various dimensions that can be used in treatments which require the removal of liquids that are in excess. Blood is pumped through a membrane that has high permeability, and the pressure gradient, through the membrane (TMP) determines the passage of water and molecules with a mechanism that is similar to glomerular filtration (convective mechanism). The fraction of filtrated liquid depends on the osmotic pressure, hydrostatic transmembrane pressure, the surface, membrane permeability and patient hematocrit. The Purema® H hemoconcentrators are designed to be used in a healthcare facility. Purema® H hemoconcentrators can be sterilized using Ethlyene Oxide (EtO). The EtO sterilized Purema® H hemoconcentrators consist of hollow fiber made of polyethersulfone (PUREMA® H), cartridge, rings, connectors, potting (fiber closure seals), and O-rings. The EtO sterilized Purema® H Hemoconcentrator is available in three models: DP07HC, and DP12HC. The main differences in these models are their total membrane surface areas.
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