PKPClass II

Immunoglobulin G (igg) Infusion System

General Hospital · 21 CFR 880.5725

An Immunoglobulin G (IgG) Infusion System is a prescription device intended for subcutaneous delivery of Immunoglobulin G (IgG) in accordance with the FDA approved labeling.

MDR events8All time

Recalls0All time

Registered firms26Currently listed

510(k) clearances7All time

Recent MDR events

8 adverse event reports on file

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EMED VERA RATE PLUS VERSA RATE PLUSJun 11, 2025
MalfunctionEmed/emed Technologies CorporationMW5171326
HIGH FLOMay 27, 2025
MalfunctionKoru Medical Systems, IncMW5170805
INF SET VERSARATE ADJ FLOWSep 27, 2024
MalfunctionUnkMW5160269
INF SET VERSARATE ADJ FLOWSep 27, 2024
MalfunctionUnkMW5160270
INTEGRATED CATCH-UP FREEDOM SYRINGE DRIVER INFUSION SYSTEMMar 31, 2020
MalfunctionRepro-med Systems, Inc Dba Koru Medical Systems1318360-2020-00001
INTEGRATED CATCH-UP FREEDOM SYRINGE DRIVER INFUSION SYSTEMDec 17, 2019
MalfunctionRepro-med Systems, Inc.1318360-2019-00005
INTEGRATED CATCH-UP FREEDOM SYRINGE DRIVER INFUSION SYSTEMNov 13, 2019
MalfunctionRepro-med Systems, Inc.1318360-2019-00004
INFUSET 930 RATE TUBINGApr 12, 2019
MalfunctionEmed Technologies CorporationMW5085862

Event type breakdown

Malfunction8

Most-reported manufacturers

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Repro-med Systems, Inc.2 Unk2 Emed Technologies Corporation1 Emed/emed Technologies Corporation1 Koru Medical Systems, Inc1 Repro-med Systems, Inc Dba Koru Medical Systems1

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

26 firms currently registered for this product code

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510(k) clearances

7 clearances for this product code

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