FDA product code QJY

Infusion Pump, Drug Specific, Pharmacy-Filled

General Hospital·Class 2·21 CFR 880.5725
US regulatory classifications
US Product Code (FDA)
QJY
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 880.5725
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Medical specialty
General Hospital
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Infusion Pump, Drug Specific, Pharmacy-Filled 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.