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QJY — Infusion Pump, Drug Specific, Pharmacy-Filled Class II

FDA Device Classification

Classification Details

Product Code
QJY
Device Class
Class II
Regulation Number
880.5725
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K243354deka research and developmentRemunity SystemNovember 27, 2024
K240256deka research and developmentRemunity SystemJune 12, 2024
K202690deka research and developmentRemunity Pump for Remodulin (treprostinil) InjectionDecember 30, 2020
K191313deka research and developmentUnity Subcutaneous Infusion System for RemodulinFebruary 21, 2020