(417 days)
The Greenmedi safety filter syringe is intended to inject the drug solutions into the human body. It is designed to prevent needle stick injuries. The 0.5um filter operates when into the human body to remove foreign substances from the drug solutions.
The Greenmedi safety filter syringe consists of a plunger that fits tightly within a barrel and a needle. The plunger can be linearly pulled and pushed along the inside of the tube, allowing the syringe to take in and expel liquid through a needle. After use, the health care professional fully depresses the Luer Assembly. Once the Luer Assembly is engaged, pulling back the plunger causes the Adapter and the attached needle to be withdrawn into the safety of the barrel. In this position against the flange, lateral pressure on the plunger results in a controlled fracture of the plunger. Both the syringe and plunger are discarded in a sharps container.
This is a 510(k) summary for a medical device called the Greenmedi Safety Filter Syringe. It does not contain information about an AI/ML powered device, therefore, the requested information cannot be extracted.
No AI/ML related information is present in the provided document.
§ 880.5860 Piston syringe.
(a)
Identification. 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. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).