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 |
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CE Certified / notified body / QM-System | CE 0344 – DEKRA / ISO 13485 :
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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
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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
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Biocompatibility: | Biocompatibility tested as required in ISO10993
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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
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