Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

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

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown