BD 515003 - PhaSeal Injector Luer Lock N35 Closed System Transfer Device, N35
The BD 515003 BD PhaSeal Injector Luer Lock N35 is a closed system transfer device component designed to support safe preparation and administration of hazardous medications. Manufactured by Becton, Dickinson and Company, this injector is part of the BD PhaSeal closed system portfolio and is engineered to maintain a sealed pathway during drug transfer.
The N35 injector features a Luer-Lock connection that allows secure attachment to compatible syringes while preserving system integrity. Its design helps prevent the escape of hazardous drug vapors or aerosols and blocks environmental contaminants from entering the system during medication handling.
| Manufacturer | Application | Specifications |
| 515003 | Injector | Luer Lock |
Key Benefits
The PhaSeal Injector N35 supports occupational safety by maintaining a mechanically closed system throughout drug preparation and administration. The Luer-Lock interface ensures a secure, leak-resistant connection, reducing the risk of disconnection during pressurized transfers.
Single-use, sterile construction supports infection prevention and eliminates risks associated with reuse. The injector integrates smoothly into established PhaSeal workflows without adding complexity for pharmacy or clinical staff.
Compatibility and Applications
The BD 515003 Injector N35 is designed exclusively for use with other compatible BD PhaSeal components. When connected within the PhaSeal system, it helps maintain a fully closed drug transfer pathway.
Typical applications include hazardous drug compounding and administration in hospital pharmacies, oncology infusion centers, cleanrooms, and clinical environments handling antineoplastic or other high-risk medications.
Usage Guidelines
The injector should be attached to a compatible syringe using the Luer-Lock connection and used according to institutional hazardous drug handling protocols. All handling should follow aseptic technique and facility policies aligned with USP and occupational safety guidance.
After use, the injector must be disposed of according to hazardous drug waste and sharps disposal procedures. The product is intended for single use only.
Certifications, Safety Standards, and Regulatory Approvals
The BD PhaSeal system, including the Injector Luer Lock N35, is manufactured under quality management systems aligned with FDA medical device regulations and internationally recognized manufacturing standards. PhaSeal devices are widely recognized for meeting the definition of a closed system transfer device under applicable regulatory guidance.
These certifications support safer drug handling environments and reinforce confidence in system performance.
Comparison with Competitor Products
Compared with open-system injectors or partial containment devices, the BD PhaSeal Injector N35 offers full mechanical containment that actively prevents both drug escape and environmental contamination. While some competitor systems rely on filters or venting mechanisms, PhaSeals sealed design provides a higher level of protection.
Healthcare facilities often select BD PhaSeal components for their proven clinical adoption, system-wide compatibility, and strong alignment with hazardous drug safety initiatives.
Typical User Profile and Application Scenarios
Typical users include pharmacists, pharmacy technicians, oncology nurses, and trained healthcare professionals responsible for preparing and administering hazardous medications.
The injector is particularly effective in oncology pharmacies, infusion suites, hospital cleanrooms, and clinical settings where regulatory compliance and staff safety are critical.
Best Practices for Use and Maintenance
Best practice includes verifying compatibility with other PhaSeal components before use and ensuring secure connections prior to drug transfer. Staff should receive training on proper PhaSeal assembly and disposal to maintain closed system integrity.
As a single-use device, no maintenance or reprocessing is required. Proper disposal after use supports compliance with hazardous drug handling and infection control policies.
Regulatory and Safety Information
The BD 515003 BD PhaSeal Injector Luer Lock N35 is classified as a regulated medical device and supports compliance with hazardous drug handling guidelines and occupational safety standards. Its closed system design aligns with institutional policies aimed at reducing exposure risk.
Following manufacturer instructions and facility procedures is essential to ensure safe, compliant use in all approved applications.
How to Order
The BD 515003 BD PhaSeal Injector Luer Lock N35 is available for purchase through the CIA Medical website. Add the product to your cart and proceed through the secure checkout process.
For bulk purchasing, oncology program support, or additional assistance, contact CIA Medical customer service at 312 275 5850 or use the contact form available on this page for prompt support.
