Device type
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Product code ONB · Class II · 21 CFR 880.5440 · General Hospital
Reconstitute and transfer antineoplastic and other hazardous drugs in healthcare setting indicated to reduce exposure of healthcare personnel to chemotherapy agents in healthcare setting.
Recent 510(k)s
No 510(k) clearances in the archive for ONB.
Recent recalls
Sep 23, 2026
Z-3161-2026
IV Sets with drip chambers
ICU Medical, Inc.
- ONB
- Class II
- Ongoing
Sep 23, 2026
Z-3159-2026
Oncology sets with drip chambers
ICU Medical, Inc.
- ONB
- Class II
- Ongoing