| Technical Detail | Fits 0.276 inch ID Tubing (7 mm) |
| Materials | PC |
| CAD Model Available | No |
| 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 |
| Product Shelf Life Non-Irradiation (months) | 60 |
| Animal Derived Ingredients (BSE/TSE) | Conforms with EMA/410/01 rev. 3 |
| California Prop. 65 | NO Substances on the California Proposition 65 list have been knowingly or intentionally added |
| Conflict Minerals | Not known to contain tantalum, tin, tungsten or gold. |
| European Pharmacopoeia (EP) 3.1.X | Product out of scope |
| 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 |
| Medicinal Substances | Does NOT intentionally contain medicinal substances |
| Nanomaterials | Does NOT intentionally contain nanomaterials |
| Pyrogens | Pyrogen free - Tested via USP <151>/<161> |
| RoHS3 (2015/863) | Conforms to requirements of RoHS 2015/863 (RoHS3) |
| EtO Compatible | Yes |
| Biocompatibility tested ISO 10993 | Yes |
| ISO 10993-X Claim Based on | Raw Material |
| USP Biocompatibility 87 | Raw materials pass USP <87> |
| USP Biocompatibility 88 | passes USP <88>, temperature not stated |
| USP Biocompatibility Claim Based On | Raw Material |
| Residual Solvents: Tested via ICH Q3C Standard | Contains NO ICH Q3C Class 1 or 2 Residual Solvents |
| Elemental Impurities: Tested via ICH Q3D Standard | Contains NO ICH Q3D Class 1, 2, 2B or 3 Elemental Impurities |
| Protein Absorption Data Available | No |
| Extractables Testing Claims | Other Report |
| Visible-Subvisible Particulate Claim | USP <788> |
| Bioburden USP 61 62 | No bioburden information available |
| Tested via USP 661.1 | Yes |
| 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.
