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U.S. Department of Health and Human Services

Product Classification

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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 CodeONB
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
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible