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5744-10100 NovaSeptum®, High Purity Application, 5 x 100 ml C-Flex®

5744-10100
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      Replacement Information
      Description
      Catalogue Number5744-10100
      Trade Name
      • NovaSeptum®
      DescriptionNovaSeptum®, High Purity Application, 5 x 100 ml C-Flex®
      References
      Product Information
      Device ConfigurationMulti-sampling
      Fitting InletFemale and male Luer-Lok™ and Inlet C-Flex® Tubing
      Fitting Outlet3-piece Luer
      Maximum Sampling Pressure0.3 bar (4,35 psi)
      Maximum Operating Temperature4-50 °C temp. range (39 -122 °F)
      Quality LevelMQ400
      Applications
      ApplicationSterility testing, Bioburden, pyrogenic testing, endotoxin testing, chemical analysis, pH analysis, fermentation applications or any other routine lab testing
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤2.15 EU/sampling device as determined by the Limulus Amebocyte Lysate (LAL) Test
      SterilitySterile
      SterilizationBeta Irradiation (e-beam) minimum 25 kGy according to ISO 11137 TIR No. 27
      Physicochemical Information
      Dimensions
      Volume5*100mL
      Materials Information
      Device Material
      • Polystyrene
      Tubing MaterialMedical grade, Thermoplastic elastomer (TPE);Inlet C-Flex
      Toxicological Information
      Safety Information according to GHS
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      Packaging Information
      Bag MaterialPUREFLEX and drainage bag: polyethylene film
      Material Size7
      Transport Information
      Supplemental Information
      Specifications
      Global Trade Item Number
      Bestellnummer GTIN
      5744-10100 04065269844457

      Documentation

      Material Qualification Dossier

      TitelVersion
      9.0

      Quality Management Dossier (Open Access)

      Title

      Qualitätszertifikate

      Titel
      NovaSeptum® Multi Sampling - 230310-501
      NovaSeptum® Multi Sampling - 240417-553
      NovaSeptum® Multi Sampling - 240903-552
      NovaSeptum® Multi Sampling - 241128-551
      NovaSeptum® Multi Sampling - 250611-558
      NovaSeptum® Multi Sampling - 250709-552
      NovaSeptum® Multi Sampling - 250805-551
      NovaSeptum® Multi Sampling - 251204-555
      This product was manufactured by a facility whicadheres to Good Manufacturing Practices guidelinesSpecial emphasis has been placed on cleanliness anenvironmental control conditions. ® - 260116-553
      This product was manufactured by a facility whicadheres to Good Manufacturing Practices guidelinesSpecial emphasis has been placed on cleanliness anenvironmental control conditions. ® - 260211-558

      Datenblatt

      Titel
      Data Sheet -NovaSeptum® SURe

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