| Technical Detail | Flow Rate 5-250 ml/h; Fits 0.118 inch ID x 0.161 inch OD Tubing (3 mm x 4.1 mm) |
| Materials | ABS Colorant Silicone |
| CAD Model Available | Yes |
| Manufacturing Environment Classification | ISO Class 8 / 100,000 / Grade D |
| Manufacturing Aids - Mold Release - Lubricant used | No |
| Colorant in Part | Yes |
| Regrind Percentage | 12 |
| Regrind Used to Manufacture This Part | Yes |
| Hazardous Goods | No |
| Animal Derived Ingredients (BSE/TSE) | Certified Animal Derived Component Free (ADCF) |
| California Prop. 65 | SOME Substances on the California Proposition 65 list have been knowingly or intentionally added |
| California Prop. 65 List Date | 12/30/2023 12:00:00 am |
| Conflict Minerals | Not known to contain tantalum, tin, tungsten or gold. |
| 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 | Pass 3.1.6 Polypropylene |
| Latex | Does NOT intentionally contain natural latex |
| Latex in Packaging | Does NOT intentionally contain natural latex |
| Medicinal Substances | Information Not Available |
| Pyrogens | Not Tested for Pyrogens |
| REACH SVHC | No Substance(s) Present Above Threshold |
| REACH SVHC Candidate List | 2024 January 23 (240 Substances) |
| EtO Compatible | Yes |
| Gamma Compatible | Yes |
| Gamma Maximum Dosage (kGy) | 25 |
| Biocompatibility tested ISO 10993 | Yes |
| ISO 10993-X Claim Based on | Finished Component |
| USP Biocompatibility 87 | Raw materials pass 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 | 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 | Other Claim |
| Bioburden USP 61 62 | Bioburden values 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.
