Search Results

The Universal Fluid Dispensing Syringe is Merit Medical's Monarch Syringe and Intellisystem Syringe intended to be used by healthcare professionals to inject fluids into the body and monitor the pressure of that fluid.

This is a general purpose syringe and inflation device with pressure monitoring capability.

This document is a 510(k) summary for a Universal Fluid Dispensing Syringe (Merit Medical's Monarch Syringe and Intellisystem Syringe) and does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria related to AI/ML performance.

The document discusses:

• Device Name: Universal Fluid Dispensing Syringe
• Common Name: Piston Syringe
• Trade Name: Intellisystem Inflation Device and Fluid Dispensing Syringe, Monarch Inflation Device and Fluid Dispensing Syringe
• Intended Use: To be used by healthcare professionals to dispense fluids to the body and monitor the pressure of that fluid.
• Technological Characteristics: Describes two models (Monarch and Intellisystem) which are 20ml volume syringes with electronic pressure monitoring capabilities and fluid dispensing mechanisms.
• Predicate Device: Merit Medical Medallion Syringe
• Regulatory Classification: Class II (Product Code: DXT)
• FDA Decision: Found substantially equivalent to pre-amendment devices, allowing market entry.

Therefore, I cannot provide the requested information as it is not present in the given text. The questions you posed are typically relevant for AI/ML-based medical devices, which this document does not describe.

Ask a specific question about this device