Epinephrine Syringe

Device Code: 2753

Product Code(s): PQX

Definition: Intended For Intramuscular Or Subcutaneous Injection Of Epinephrine.

Device Classification Information

Device Type ID2753
Device NameEpinephrine Syringe
Physical StateA Piston Syringe Is A Device Intended For Medical Purposes That Consists Of A Calibrated Hollow Barrel And A Movable Plunger.
Technical MethodA 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 AreaIntramuscular Or Subcutaneous.
Regulation DescriptionPiston Syringe.
Regulation Medical SpecialtyGeneral Hospital
Review PanelGeneral 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 Type510(k)
CFR Regulation Number880.5860 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodePQX
GMP ExemptNo
Summary MRIneligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2753
DeviceEpinephrine Syringe
Product CodePQX
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionPiston Syringe.
CFR Regulation Number880.5860 [🔎]
TPLC Last Update: 2019-04-02 20:18:19

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