Description
The BD PosiFlush XS is an essential tool for healthcare professionals, designed to maintain the patency of vascular access devices with ease and reliability. Pre-filled with a sterile, non-pyrogenic, isotonic 0.9% sodium chloride solution, this syringe is crafted for single use, ensuring optimal hygiene and convenience.
Key Features
- Standardized Design: All sizes (3 mL, 5 mL, 10 mL) feature a consistent 10 mL barrel diameter. This design minimizes injection pressure, reducing the risk of catheter damage.
- Secure Connection: Equipped with a BD Luer-Lok™ tip, it provides a secure connection, lowering the risk of contamination.
- Clear Labeling: Bold and clear labeling helps in easy identification, reducing medication errors.
- Aseptic Packaging: Each syringe is individually packaged, available in blister pack or flow wrap, for aseptic presentation.
Material Composition
- Components: Made from polypropylene for the barrel, plunger rod, and tip cap, with a latex-free elastomer stopper.
- Lubrication: Utilizes medical-grade silicone oil.
- Labeling: Constructed from polypropylene.
Safety and Compliance
- Biocompatibility: Free from natural rubber latex, BPA, and phthalates. Complies with ISO 10993 for biocompatibility.
- Sterilization: Terminally sterilized by moist heat, ensuring a Sterility Assurance Level of 10⁻⁶.
- Shelf Life: Offers a 3-year shelf life with specific storage conditions to maintain integrity.
Packaging and Storage
- Packaging: 30 units per shelf box and 240 units per shipping case, using polypropylene, chipboard, and corrugated carton materials.
- Storage Conditions: Recommended storage between 15°C and 25°C, with specific transport conditions.
Regulatory Compliance
- Medical Device Classification: Classified as a Class III medical device, CE marked, and manufactured under ISO 13485:2016.
- Standards Adherence: Complies with various EN ISO standards for sterility, packaging, labeling, and risk management.
Instructions for Use
Before use, inspect the packaging and solution. Open aseptically, ensure the tip cap remains uncontaminated, and expel air before connecting to the vascular access device. Flush the required volume slowly and dispose of the syringe after use. Reuse or re-sterilization is not recommended.
The BD PosiFlush XS syringe is a reliable, high-quality solution for maintaining vascular access device patency, supporting healthcare professionals with its robust design and comprehensive compliance with medical standards.
