# Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
> **Product code: ONB** · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.5440
## Classification
- **FDA Product Code:** ONB
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 880.5440
- **Review panel:** HO
- **Medical specialty:** General Hospital
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 41
- **Registered establishments:** 40
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=ONB)
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