Technical data

    In this table you will find the most important technical data (specifications) for the CytoSorb 300 adsorber.
    For further questions please contact us.

    Details
    dosage
    CE Certified / notified body / QM-System
    CE 0344 – DEKRA / ISO 13485 :
    Intended use:
    CytoSorb is indicated for use in conditions where elevated levels of cytokines and/or bilirubin and/or
    myoglobin exist.
    CytoSorb is indicated for use intraoperatively during cardio-pulmonary bypass surgery for the
    removal of P2Y12-Inhibitor Ticagrelor and/or Factor Xa-Inhibitor Rivaroxaban.
    CytoSorb may be used with extracorporeal blood circuit, such as intermittent hemodialysis,
    continuous renal replacement therapy (CRRT), cardiopulmonary bypass (CPB) and
    extracorporeal membrane oxygenation (ECMO)
    Adsorber blood volume:
    150 ml
    Blood flow rates min-max:
    Recommended blood flow rates:
    100 – 700 ml/min
    150 – 700 ml/min
    Max. treatment duration:
    24 hours
    Further details:
    Latex- and PHT free product
    Sterilization / shelf life / storage conditions:
    Gamma sterilization / 3 years / 1°C to 40°C
    Maximum pressure limit:
    760 mmHg
    Flow resistance (Hkt 23 +/- 3% @ 37+/- 1°C):
    Qb <= 700 ml/min 140 mmHg
    Qb <= 500 ml/min 090 mmHg
    Qb <= 200 ml/min 030 mmHg
    GMDN Code:
    34422
    Surface:
    45,000 square meters
    Adsorbent:
    Proprietary and patented cross-linked divinylbenzene polymer, exclusively produced
    by CytoSorbents in the USA
    Adsorption Spectrum:
    Small and mid size hydrophobic molecules up to a size of approximately 60kDa
    Biocompatibility:
    Biocompatibility tested as required in ISO10993
    Mode of operation covered by IFU:
    Many extracorporeal blood circuit (Hemoperfusion (HP), Intermittent hemodialysis (HD),
    continuous renal replacement therapy (CRRT), cardiopulmonary bypass (CPB),
    extracorporeal membrane oxygenation (ECMO/ECLS)
    Priming fluid, procedure and duration:
    Flushing with 2 liters of sterile isotonic saline (NaCL 0,9%) / Priming takes approximately
    5 minutes. CytoSorb contains pre-loaded physiological saline with a pH level of 6.8 pre-flush.
    CytoSorb does not require priming/coating with heparin
    Therapy duration:
    CytoSorb can be used up to 24hrs. Consider changing CytoSorb after 12hr for the first 24hrs
    when indicated, in cases of hemodynamic instability, high bilirubin, no further substance removal.
    Anticoagulation:
    Possible with heparin or citrate
    CytoSorb Literature Database