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U.S. Department of Health and Human Services

Product Classification

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Device lockbox
Regulation Description Infusion pump.
Definition The lockbox is intended to hold a perfusor space infusion pump and keep the medication syringe contained within the pump relatively secure.
Physical State lockbox is a clear polycarbonate enclosure with a window to access the interface keys on the B. Braun Perfusor Space Syringe Infusion Pump. It has a lockable front door, a carry handle and a lockable pole clamp
Technical Method The lockbox is an accessory to the Perfusor Space Syringe infusion Pump. It has a lockable front door and may be attached to an IV pole with a lockable pole clamp. The lockbox is a polycarbonate enclosure made to relatively secure access to the pump and the syringe containing medication within the pump.
Target Area Export Only
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodePOT
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
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