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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device immunoglobulin g (igg) infusion system
Regulation Description Infusion pump.
Definition 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.
Product CodePKP
Regulation Number 880.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
EMED TECHNOLOGIES CORPORATION
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2024 2 2
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 1 1
Crack 1 1
Device Markings/Labelling Problem 1 1
Defective Device 1 1
Delivered as Unsterile Product 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
Insufficient Information 1 1

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