# Infusion Pump, Drug Specific, Pharmacy-Filled
> **Product code: QJY** · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.5725
## Classification
- **FDA Product Code:** QJY
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 880.5725
- **Review panel:** HO
- **Medical specialty:** General Hospital
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

A Pharmacy-Filled, Drug Specific Infusion System is a prescription device intended for delivery of a specific drug in accordance with the FDA approved labeling and may be filled at a location other than point of care.

## Market data
- **Cleared 510(k) submissions:** 4
- **Registered establishments:** 7
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QJY)
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