Extension Line, Hemostasis Valve with Male Luer Lock & Female Cap to 3-Way Stopcock & Male Luer Cap

80400

Technical Features

4 FR - 6 FR (0.053 inch - 0.078 inch, 1.35 mm - 2 mm); 9.5 inch Length (241.3 mm)

Materials

ABS PC HDPE Colorant ABS PC PC PC PVC Silicone PC

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Technical Detail 4 FR - 6 FR (0.053 inch - 0.078 inch, 1.35 mm - 2 mm); 9.5 inch Length (241.3 mm)
Materials ABS PC HDPE Colorant ABS PC PC PC PVC Silicone PC
CAD Model Available Yes
Manufacturing Environment Classification ISO Class 8 / 100,000 / Grade D
Manufacturing Aids - Mold Release - Lubricant used No
Colorant in Part No
Regrind Used to Manufacture This Part No
Hazardous Goods No
Animal Derived Ingredients (BSE/TSE) Certified Animal Derived Component Free (ADCF)
Conflict Minerals Not known to contain tantalum, tin, tungsten or gold.
EU MDR 10.4.1 (CMR/ED) Substance(s) Present Above Threshold
EU MDR 10.4.1 (CMR/ED) Substance List Annex VI to CLP_ATP17 - 17 December 2022
European Pharmacopoeia (EP) 3.1.X Information Not Available
Human Derived Ingredients Does NOT intentionally contain human derived ingredients
Latex Does NOT intentionally contain natural latex
Latex in Packaging Does NOT intentionally contain natural latex
PFAS Does NOT intentionally contain PFAS
PFAS in Packaging Does NOT intentionally contain PFAS
Pyrogens Not Tested for Pyrogens
REACH SVHC Substance(s) Present Above Threshold
REACH SVHC Candidate List 2023 January 17 (233 Substances)
RoHS3 (2015/863) Does not conform to requirements of RoHS 2015/863 (RoHS3)
EtO Compatible Yes
USP Biocompatibility 88 passes USP <88>, temperature not stated
USP Biocompatibility Claim Based On Finished Component
Residual Solvents: Tested via ICH Q3C Standard No ICH Q3C Testing Performed
Elemental Impurities: Tested via ICH Q3D Standard No ICH Q3D Testing Performed
Protein Absorption Data Available No
Extractables Testing Claims No Extractables Testing Performed
Bioburden USP 61 62 No bioburden information available
Tested via USP 661.1 No
Integrity Tested? No

The products in our inventory are intended solely for use as components for further manufacturing, processing or incorporation into a finished device. These products are not intended for use as finished devices. Customers are solely responsible for determining whether a Qosina component product is appropriate for customer’s intended use and for ensuring that the use of the component product is in compliance with applicable laws. Our components are not available for sale to hospitals, physicians, and pharmacists.

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