| Technical Detail | 58 psi |
| Materials | PC HDPE Colorant |
| CAD Model Available | No |
| Manufacturing Environment Classification | ISO Class 8 / 100,000 / Grade D |
| Colorant in Part | Yes |
| 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_ATP20 - 01 February 2025 |
| European Pharmacopoeia (EP) 3.1.X | Information Not Available |
| PFAS | Does NOT intentionally contain PFAS |
| PFAS in Packaging | Does NOT intentionally contain PFAS |
| REACH SVHC | No Substance(s) Present Above Threshold |
| REACH SVHC Candidate List | 2024 January 23 (240 Substances) |
| EtO Compatible | Yes |
| Gamma Compatible | Yes |
| 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.
