Tradeshow Disclaimers
  • The SmartDose® on-body delivery system is intended for PRESENTATION/DEMONSTRATION PURPOSES ONLY. The device is not available for sale or use and will not be put into service until its conformity has been declared. West's SmartDose® on-body delivery system is not independently cleared or approved by any Regulatory Body for general healthcare professional or patient use, nor is it available for general commercial purchase. Its distribution and use are subject to applicable regulatory requirements for clinical investigation, and for marketing authorization, as used in combination with a specific drug or biological product. Each component of a combination product is subject to the requirements established by the Regulatory Body for that component (drug, biologic or device). The regulatory process can be more complicated for combination products including an evaluation of the product characteristics, delivery system and its functionality, intended users and use environment(s), as well as the potential for undesirable interactions between the drug or biologic and the delivery system. As a result, we note that the SmartDose® on-body delivery system’s compatibility with any particular drug or biologic must be confirmed, and its ability to achieve the desired patient benefits must also be confirmed, on a case-by-case basis in a manner sufficient to meet Regulatory Body requirements. Failure to follow product instructions for use may result in compromised sterility; contamination; leakage (including possible exposure to medication); and/or underdosing. Product misuse could potentially lead to needlestick injury, user and/or patient exposure to pathogens or infection, and/or suboptimal or delayed therapy. Important product and safety information and warnings available at: https://www.westpharma.com/products/self-injection-platforms/smartdose.
  • West’s SelfDose® patient-controlled injector is not independently cleared or approved by any Regulatory Body for general healthcare professional or patient use, nor is it available for general commercial purchase. Its distribution and use are subject to applicable regulatory requirements for clinical investigation, and for marketing authorization, as used in combination with a specific drug or biological product. Each component of a combination product is subject to the requirements established by the Regulatory Body for that component (drug, biologic or device). The regulatory process can be more complicated for combination products including an evaluation of the product characteristics, delivery system and its functionality, intended users and use environment(s), as well as the potential for undesirable interactions between the drug or biologic and the delivery system. As a result, we note that the SelfDose® patient-controlled injector's compatibility with any particular drug or biologic must be confirmed, and its ability to achieve the desired patient benefits must also be confirmed, on a case-by-case basis in a manner sufficient to meet Regulatory Body requirements. The assembled appearance of the SelfDose® patient-controlled injector is for demonstrative purposes only. The SelfDose® patient-controlled injector is intended to be distributed as an integrated device and is provided disassembled for assembly with, or around, the specific drug or biologic. Products are shown for INFORMATION purposes only. Important product and safety information and warnings available at: https://www.westpharma.com/products/self-injection-platforms/selfdose.
  • Vial Adapter™, Vented Vial Adapter™, Swabable Vial Adapter™, and Swabable Vented Vial Adapter™ transfer devices carry the CE mark (0344). Vial Adapter™, Vented Vial Adapter™, and Swabable Vial Adapter™ transfer devices are 510(k) cleared by the United States Food and Drug Administration. Products are shown for INFORMATION purposes only and may not be approved for marketing in specific regions. Distribution and use are subject to applicable regulatory approvals and requirements for medical devices. The Vial Adapter™ and Vented Vial Adapter™ transfer devices are configurable and may not be suitable for use with all drugs. The Swabable Vial Adapter™ transfer device and the Swabable Vented Vial Adapter™ transfer device inhibit microbial ingress for up to 24 hours and 72 hours, respectively, when used in accordance with the product instructions for use and proper aseptic technique. The use of the Swabable Vial Adapter™ and the Swabable Vented Vial Adapter™ transfer devices should not be interpreted as modifying, extending, or superseding a drug manufacturer's labeling recommendations for storage and expiration dating. The Swabable Vial Adapter™ and the Swabable Vented Vial Adapter™ transfer devices are not compatible for use with all drug products. Refer to drug manufacturer's labeling and use instructions for device configuration compatibility and for shelf life and sterility information of opened or reconstituted drug product. Failure to follow product instructions for use may result in compromised sterility; contamination; leakage (including possible exposure to medication); and/or inadequate medication reconstitution, transfer, and/or dosing. Product misuse could potentially lead to user and/or patient infection, suboptimal therapy, and/or delay in therapy. Please contact your West Pharmaceutical Services, Inc. (West) representative for product availability. Important product and safety information and warnings at: https://www.westpharma.com/products/vial-adapter-systems/vial-adapters.
  • The Mix2Vial® transfer device is 510(k) cleared by the United States Food and Drug Administration and carries the CE mark (0344). Products are shown for INFORMATION purposes only and may not be approved for marketing in specific regions. Distribution and use are subject to applicable regulatory approvals and requirements for medical devices. Failure to follow product instructions for use may result in loss of sterility; contamination; inadequate medication transfer, dilution, withdrawal, and/or dosing. Product misuse could potentially lead to user and/or patient infection, suboptimal therapy, and/or delay in therapy. Please contact your West Pharmaceutical Services, Inc. (West) representative for product availability. Important product and safety information and warnings at: https://www.westpharma.com/-/media/westpharma/files/products/mix2vial-indication-safety-and-warnings.pdf
  • Materials are intended for healthcare professionals only.