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510(k) Data Aggregation

    K Number
    K243920
    Manufacturer
    Date Cleared
    2025-09-19

    (273 days)

    Product Code
    Regulation Number
    876.5860
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Purema® H Hemoconcentrator - Pediatric 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 - Pediatric model DP03HC is intended to be used for pediatric patients.

    Device Description

    The Purema® H Hemoconcentrator - Pediatric is a single use hemoconcentrators containing filters composed of a hollow fiber made of polyethersulfone (PUREMA® H). The Purema® H Hemoconcentrator - Pediatric is a hemoconcentrators 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 transmembrane pressure (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 Hemoconcentrator - Pediatric is designed to be used in a healthcare facility.

    Purema® H Hemoconcentrator - Pediatric is sterilized using Ethlyene Oxide (EtO). The EtO sterilized device consists of hollow fiber made of polyethersulfone (PUREMA® H), cartridge, rings, connectors, potting (fiber closure seals), and O-rings. The EtO sterilized Purema® H Hemoconcentrator - Pediatric is available in model DP03HC.

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