Part number 49012 is an integrated Disposable Optical Transducer (iDOT™) gamma-stable bag port. This component allows for non-invasive in situ monitoring of O2 (0-100%) and is pre-calibrated for plug-and-play use. This product features a POE bag port with PVB/LDPE sensing film, with materials that meet USP Class VI requirements. Designed to work with Polestar Technologies DSP Series Optical Process Monitoring products, the bag port would attach to a Polestar fiber optic cable.
| Technical Detail | Fits Polestar Technologies Fiber Optic Cable |
| Materials | Polyolefin PVB LDPE |
| CAD Model Available | No |
| Manufacturing Environment Classification | Controlled but not formally classified |
| Manufacturing Aids - Mold Release - Lubricant used | No |
| Colorant in Part | No |
| Regrind Used to Manufacture This Part | No |
| Hazardous Goods | No |
| Product Shelf Life Non-Irradiation (months) | 24 |
| Product Shelf Life Post-Irradiation (months) | 24 |
| California Prop. 65 | NO Substances on the California Proposition 65 list have been knowingly or intentionally added |
| California Prop. 65 List Date | 1/27/2023 12:00:00 am |
| Conflict Minerals | Not known to contain tantalum, tin, tungsten or gold. |
| Human Derived Ingredients | Does NOT intentionally contain human derived ingredients |
| Latex | Does NOT intentionally contain natural latex |
| Latex in Packaging | Does NOT intentionally contain natural latex |
| Medicinal Substances | Does NOT intentionally contain medicinal substances |
| Nanomaterials | Does NOT intentionally contain nanomaterials |
| Pyrogens | Not Tested for Pyrogens |
| REACH SVHC | No Substance(s) Present Above Threshold |
| RoHS3 (2015/863) | Conforms to requirements of RoHS 2015/863 (RoHS3) |
| EtO Compatible | Yes |
| Gamma Compatible | Yes |
| Gamma Maximum Dosage (kGy) | 50 |
| USP Biocompatibility 87 | Finished component passes USP<87> |
| 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 |
| Bioburden USP 61 62 | No bioburden information 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.
