Product Classification

• Device: closed antineoplastic and hazardous drug reconstitution and transfer system
• Regulation Description: Intravascular administration set.
• Definition: Reconstitute and transfer antineoplastic and other hazardous drugs in healthcare setting indicated to reduce exposure of healthcare personnel to chemotherapy agents in healthcare setting.
• Physical State: Vial adator with piercing spikes, contain Luer-Lock connector fitted with elastomeric membrane to provide a sealed connection between syringe, I.V. administration set or tranfer bag. May contain side pressure-equalizing protector unit. May contain needle-free access port.
• Technical Method: Placed over vial or container containing the chemotheraphy drug
• Target Area: Device is not act on any part of body. I.V. infusion devices, catheters, drug container closure system.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: ONB
• Premarket Review: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3); Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
• Submission Type: 510(k)
• Regulation Number: 880.5440
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 6-273 ISO 23908 First edition 2011-06-11
  Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
• 6-507 ISO 23908 Second Edition 2024-12
  Sharps injury protection - Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration - Requirements and test methods

Third Party Review

Not Third Party Eligible