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U.S. Department of Health and Human Services

Product Classification
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Device lockbox (export only)
Definition The lockbox is intended to hold an 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 infusion pump. It has a lockable front door, a carry handle and a lockable pole clamp.
Technical Method The lockbox is an accessory to an 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 Medication
Review Panel General Hospital
Product CodePOT
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Not Classified Reason For Export Only
Submission Type Contact ODE
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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