Definition: Intended For Intramuscular Or Subcutaneous Injection Of Epinephrine.
Device Type ID | 2753 |
Device Name | Epinephrine Syringe |
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 Lu |
Target Area | Intramuscular Or Subcutaneous. |
Regulation Description | Piston Syringe. |
Regulation Medical Specialty | General Hospital |
Review Panel | General Hospital |
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) |
CFR Regulation Number | 880.5860 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | PQX |
GMP Exempt | No |
Summary MR | Ineligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2753 |
Device | Epinephrine Syringe |
Product Code | PQX |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Piston Syringe. |
CFR Regulation Number | 880.5860 [🔎] |