| Technical Detail | Fits 3/8 inch ID Tubing (0.375 inch, 9.53 mm) |
| Materials | TPE Colorant PBT |
| CAD Model Available | No |
| Manufacturing Environment Classification | Controlled but not formally classified |
| Manufacturing Aids - Mold Release - Lubricant used | Information Not Available |
| Colorant in Part | Yes |
| Regrind Used to Manufacture This Part | Information Not Available |
| Hazardous Goods | No |
| Product Shelf Life Non-Irradiation (months) | 36 |
| Product Shelf Life Post-Irradiation (months) | 36 |
| Animal Derived Ingredients (BSE/TSE) | Certified Animal Derived Component Free (ADCF) |
| California Prop. 65 | Information Not Available |
| Conflict Minerals | Not known to contain tantalum, tin, tungsten or gold. |
| European Pharmacopoeia (EP) 3.1.X | Information Not Available |
| Human Derived Ingredients | Information Not Available |
| Latex | Information Not Available |
| Latex in Packaging | Information Not Available |
| Medicinal Substances | Information Not Available |
| Nanomaterials | Information Not Available |
| Pyrogens | Pyrogen free - Tested via USP <85> |
| REACH SVHC | No Substance(s) Present Above Threshold |
| REACH SVHC Candidate List | 2023 June 14 (235 Substances) |
| RoHS3 (2015/863) | Does not conform to requirements of RoHS 2015/863 (RoHS3) |
| Gamma Compatible | Yes |
| Gamma Maximum Dosage (kGy) | 50 |
| Biocompatibility tested ISO 10993 | Yes |
| ISO 10993-X Claim Based on | Finished Component |
| USP Biocompatibility 87 | Finished component passes USP<87> |
| 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 | Other Report |
| Visible-Subvisible Particulate Claim | USP <788> |
| Bioburden USP 61 62 | Bioburden values 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.
