| Technical Detail | 80A Durometer; 0.01 inch ID x 0.03 inch OD (0.25 mm x 0.76 mm) x 500 ft coil (152.4 m) |
| Materials | PVC |
| CAD Model Available | No |
| Packaging | 500 ft coil (152.4 m) |
| Manufacturing Environment Classification | No environmental controls |
| Manufacturing Aids - Mold Release - Lubricant used | No |
| Hazardous Goods | No |
| Product Shelf Life Non-Irradiation (months) | 36 |
| Animal Derived Ingredients (BSE/TSE) | Conforms with EMA/410/01 rev. 3 |
| 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 |
| 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 | Does NOT intentionally contain natural latex |
| Latex in Packaging | Does NOT intentionally contain natural latex |
| Medicinal Substances | Information Not Available |
| Nanomaterials | Information Not Available |
| PFAS | Does NOT intentionally contain PFAS |
| PFAS in Packaging | Information Not Available |
| Pyrogens | Not Tested for Pyrogens |
| 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 | Yes |
| Gamma Compatible | Yes |
| Gamma Maximum Dosage (kGy) | 25 |
| Biocompatibility tested ISO 10993 | No |
| USP Biocompatibility 87 | Information Not Available |
| USP Biocompatibility 88 | passes USP <88> 121C |
| USP Biocompatibility Claim Based On | Raw Material |
| 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 |
| Visible-Subvisible Particulate Claim | Information Not Available |
| Bioburden USP 61 62 | No bioburden information available |
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.
