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 Code | QDM |
Premarket Review |
Office of 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 |
|
|