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5444-90020 MilliporeNovaSeptum^®, Accurate Volume Application, 5 x 20 ml C-Flex®

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

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Overview

Replacement Information

Description
Catalogue Number	5444-90020
Trade Name	NovaSeptum^®
Description	NovaSeptum^®, Accurate Volume Application, 5 x 20 ml C-Flex®

References

Product Information
HS Code	9018 39 99
Device Configuration	Multi-sampling
Fitting Inlet	Female and male Luer-Lok™ and Inlet C-Flex® Tubing
Fitting Outlet	Male Luer
Maximum Sampling Pressure	0.5 bar (7.25 psi)
Maximum Operating Temperature	4-50 °C temp. range (39 -122 °F)
Quality Level	MQ400

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

Biological Information
Bacterial Endotoxins	Aqueous extraction contains ≤2.15 EU/sampling device as determined by the Limulus Amebocyte Lysate (LAL) Test
Sterility	Sterile
Sterilization	Beta Irradiation (e-beam) minimum 25 kGy according to ISO 11137 TIR No. 27

Physicochemical Information

Dimensions
Volume	5*20mL

Materials Information
Device Material	polycarbonate
Tubing Material	Medical grade, platinum-cured silicone;Inlet C-Flex®

Toxicological Information

Safety Information according to GHS

Safety Information

Product Usage Statements

Storage and Shipping Information

Packaging Information
Bag Material	drainage bag: polyethylene film
Material Size	5

Transport Information

Supplemental Information

Specifications

Global Trade Item Number
Catalog Number	GTIN
5444-90020	04065269844488

Documentation

Material Qualification Dossier

Title	Version
EMPROVE® Material Qualification Dossier - 5444-90020	3.0

Quality Management Dossier (Open Access)

Title
NovaSeptum®, Accurate Volume Application, 5 x 20 ml C-Flex®

Certificates of Quality

Title
NovaSeptum® Multi Sampling - 230310-505
NovaSeptum® Multi Sampling - 240924-551

Data Sheet

Title
Data Sheet -NovaSeptum® SURe

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