| Technical Detail | 1 Liter; 2 Tubes 0.258 inch ID (6.55 mm) |
| Materials | PVC PVC |
| CAD Model Available | No |
| Manufacturing Environment Classification | ISO Class 8 / 100,000 / Grade D |
| Manufacturing Aids - Mold Release - Lubricant used | Yes |
| Colorant in Part | No |
| Regrind Percentage | 12 |
| Regrind Used to Manufacture This Part | Yes |
| Hazardous Goods | No |
| Animal Derived Ingredients (BSE/TSE) | Information Not Available |
| California Prop. 65 | Information Not Available |
| Conflict Minerals | Not known to contain tantalum, tin, tungsten or gold. |
| EU MDR 10.4.1 (CMR/ED) | No Substance(s) Present Above Threshold |
| EU MDR 10.4.1 (CMR/ED) Substance List | Annex VI to CLP_ATP18 - 01 December 2023 |
| 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 | Information Not Available |
| Medicinal Substances | Does NOT intentionally contain medicinal substances |
| Nanomaterials | Does NOT intentionally contain nanomaterials |
| Pyrogens | Not Tested for Pyrogens |
| REACH SVHC | No Substance(s) Present Above Threshold |
| REACH SVHC Candidate List | 2023 January 17 (233 Substances) |
| RoHS3 (2015/863) | Information Not Available |
| Gamma Compatible | Yes |
| Biocompatibility tested ISO 10993 | No |
| USP Biocompatibility 87 | Information Not Available |
| USP Biocompatibility 88 | Information Not Available |
| 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 |
| Visible-Subvisible Particulate Claim | Information Not Available |
| Bioburden USP 61 62 | No bioburden information available |
| Tested via USP 661.1 | No |
| Integrity Tested? | Yes, routine random samples are tested |
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.
