| Technical Detail | 9/16 inch Diameter (0.563 inch, 14.3 mm); 1.9 - 2.3 psi CP |
| Materials | Acrylic PP SS Silicone AL |
| CAD Model Available | Yes |
| Manufacturing Environment Classification | Controlled but not formally classified |
| Hazardous Goods | No |
| Product Shelf Life Non-Irradiation (months) | No shelf life indicated by the supplier |
| California Prop. 65 | SOME Substances on the California Proposition 65 list have been knowingly or intentionally added |
| California Prop. 65 List Date | 12/29/2023 12:00:00 am |
| 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 |
| Latex | Does NOT intentionally contain natural latex |
| Nanomaterials | Does NOT intentionally contain nanomaterials |
| PFAS | Does NOT intentionally contain PFAS |
| REACH SVHC | No Substance(s) Present Above Threshold |
| REACH SVHC Candidate List | 2023 June 14 (235 Substances) |
| RoHS3 (2015/863) | Conforms to requirements of RoHS 2015/863 (RoHS3) |
| EtO Compatible | Information Not Available |
| Gamma Compatible | Information Not Available |
| Steam Compatible | Information Not Available |
| X-Ray Compatible | Information Not Available |
| Biocompatibility tested ISO 10993 | Yes |
| 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? | 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.
