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The Monarch Safety Blood Collection Set is a sterile, multi-sample, single use fixed winged blood collection set. The device is indicated for general medical use in Healthcare Facilities by medical professionals with the patient population to include both adolescent and adult patients. The Monarch Blood Collection Set is intended to be used with evacuated blood collection tubes and/or blood culture bottles. The Monarch Blood Collection device is to remain under direct supervision of a medical professional during use. The Monarch Blood Collection set includes a safety feature to prevent accidental needlestick injury during normal handling and disposal. The safety feature is initiated by full manual retraction of the needle from the venipuncture site to prevent accidental needlesticks during handling and disposal. The Monarch Blood Collection set is not intended for infusion, IV administration, or transfusion.

The Monarch Blood Collection Set is a sterile, single-use, winged needle with tubing and luer connector. Each Monarch Blood Collection device is individually wrapped in a blister pouch. Monarch Blood collection sets include configurations for three (3) needle gauges (21, 23, 25) each with a tubing length of 12 inches. All the models are included with the back-end needle and a vacutainer holder. A blood collection assembly, comprises of a needle assembly fixedly coupled to a fingeractivated actuator and tubing, the needle assembly comprising a needle; a hub including a channel in a top surface of the hub, a proximal end and a distal end, the distal end defining a cavity and a distal passageway, the channel slidably engaging the fingeractivated actuator such that when the finger-activated actuator is moved from a first position at a distal end of the hub to a second position toward a proximal end of the hub; an active closure assembly including a door and a biasing mechanism positioned within the cavity such that when the finger-activated actuator is in the second position, the biasing mechanism operates to move the door along the cavity to contact the needle; and a support wall positioned adjacent the cavity such that, when the finger-activated actuator is in the second position, the needle contacts the support wall. Nature of contact duration for the device is limited exposure ≤ 24 h. Nature of body contact is external communicating device: Circulating blood.