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U.S. Department of Health and Human Services

Product Classification

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Device midazolam syringe
Regulation Description Piston syringe.
Definition Intended for intramuscular injection of midazolam.
Physical State A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger.
Technical Method A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle.
Target Area Intramuscular
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeQDM
Premarket Review Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Submission Type 510(k)
Regulation Number 880.5860
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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