inforMED
QJYClass II

Infusion Pump, Drug Specific, Pharmacy-filled

General Hospital · 21 CFR 880.5725

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.

MDR events351All time
Recalls0All time
Registered firms13Currently listed
510(k) clearances4All time

Recent MDR events

351 adverse event reports on file

See all →

Event type breakdown

Malfunction260
Injury87
Death3
Other1

Most-reported manufacturers

See all →
Millyard Advanced Medical Products, Llc263Millyard Advanced Medical Products Llc22Deka Research & Development Corp.15Millyard Advanced Medical Products Llc.13Unknown12Unk6United Therapeutics /deka Research & Development Corp.5United Therapeutics / Deka Research & Development Corp.2

Recalls

0 recall events for this product code

See all →

No recalls on file for this product code.

Registered firms

13 firms currently registered for this product code

See all →

510(k) clearances

4 clearances for this product code

See all →