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5844-80060 NovaSeptum®, Bottle Application, 5 x 60 ml C-Flex®

Sterility testing, Bioburden, pyrogenic testing, endotoxin testing, chemical analysis, pH analysis, fermentation applications or any other routine lab testing

5844-80060
5  
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      Overview

      Replacement Information
      Description
      Catalogue Number5844-80060
      Trade Name
      • NovaSeptum®
      DescriptionNovaSeptum®, Bottle Application, 5 x 60 ml C-Flex®
      References
      Product Information
      HS Code9018 39 99
      Device ConfigurationMulti-sampling
      Fitting InletFemale and male Luer-Lok™ and Inlet C-Flex® Tubing
      Fitting OutletMale Luer/Bottle cap
      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
      SterilizationGamma irradiation minimum 25 kGy according to ISO 11137
      Physicochemical Information
      Dimensions
      Volume5*60mL
      Materials Information
      Bottle Materialpolyethylene Terephtalate glycol
      Tubing MaterialMedical grade, Thermoplastic elastomer (TPE)
      Toxicological Information
      Safety Information according to GHS
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      Packaging Information
      Bag Materialdrainage bag: polyethylene film
      Material Size5
      Transport Information
      Supplemental Information
      Specifications
      Global Trade Item Number
      Catalogue Number GTIN
      5844-80060 04065269844464

      Documentation

      Material Qualification Dossier

      TitleVersion
      7.0

      Quality Management Dossier (Open Access)

      Title

      Certificates of Quality

      Title
      NovaSeptum® Multi Sampling - 230310-503
      NovaSeptum® Multi Sampling - 240711-551
      NovaSeptum® Multi Sampling - 240918-554
      NovaSeptum® Multi Sampling - 241202-554
      NovaSeptum® Multi Sampling - 250320-551
      NovaSeptum® Multi Sampling - 250611-555

      Data Sheet

      Title
      Data Sheet -NovaSeptum® SURe

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