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U.S. Department of Health and Human Services

Product Classification

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Device hizentra infusion system
Regulation Description Infusion pump.
Definition A hizentra infusion system is a prescription device intended for subcutaneous delivery of hizentra (immune globulin subcutaneous (human), 20% liquid) in accordance with the fda approved hizentra labeling.
Physical State A Hizentra Infusion System includes the delivery device, reservoir or syringe, and any administration sets and / or subcutaneous catheters or needles to infuse Hizentra into subcutaneous tissue.
Technical Method A Hizentra Infusion System infuses Hizentra into subcutaneous tissue in accordance with FDA approved Hizentra labeling.
Target Area In accordance with FDA approved labeling, Hizentra is for subcutaneous infusion only.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodePKP
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type 510(k)
Regulation Number 880.5725
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible