FDA product code ONB

Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

General Hospital·Class 2·21 CFR 880.5440
US regulatory classifications
US Product Code (FDA)
ONB
View Product Code Classification →
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 880.5440
View CFR Regulation →
Medical specialty
General Hospital
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

Search keywords
About this record

Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System is a medical device type in the General Hospital specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.