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The Kurin Blood Culture Collection Set is intended to obtain blood samples through the patient's vasculature via venipuncture or Peripheral IV (PIV) access. As it enters the Kurin Lock, blood initially fills a side channel then flows into the sample collection device (syringe or bottle) via an adjoining sampling channel to reduce blood culture contamination rates *. When supplied with a pressure-rated extension set, the pressure-rated extension set is intended to be utilized separately with infusions systems to administer IV fluids, medications, blood products into the patient's vascular system and may be safely used with power injectors at pressures up to 325 psi. *The Kurin Blood Collection System is for use as a blood collection system and its Kurin Lock allows the specimen of blood from the patient to be sidelined prior to the test sample to reduce the frequency of blood culture contamination when contaminates are present in the initial blood sample compared to blood cultures drawn using standard practice without the Kurin Lock.

The Kurin Blood Culture Collection Set is a sterile, single-use device that includes a vasculature connection (i.e., winged needle, male luer connection), flexible tubing, blood lock mechanism, and blood culture bottle holder (when supplied). The blood culture bottle holder varies between device models. Refer to the primary labeling for the compatible culture bottle. The Subject Device is intended to be used with the adult and pediatric population. The main purpose of the Subject Device is to obtain blood samples by transferring from the patient to a culture bottle or collection container. Venipuncture sets incorporate a needle-safe feature that covers the needle prior to disposal to aid in the prevention of needlestick injury if activated after the blood draws. Venipuncture needles include 21 and 23 gauge. Various Peripheral IV (PIV) sets incorporate a pressure-rated extension set with slide clamp that, when detached from the blood culture collection set, can be used for infusion purposes. The unique technology with the Subject Device is the blood lock mechanism (i.e., Kurin Lock). Upon access to the patient's vasculature, the Subject Device uses the patient's blood pressure to push an initial portion of blood that could contain bacterial contaminants (e.g., skin plugs) into the side channel. After the side channel is filled, flow stops until a collection device (i.e., blood culture bottle, vacutainer tube, syringe) is attached. The attachment of a collection device draws additional blood through the Subject Device and into the collection device. The initial portion of blood in the side channel is not isolated from this additional incoming blood, the amount of contamination reaching the collection device is dramatically reduced.

The Kurin Blood Culture Collection Set is a winged blood collection needle with flexible tubing intended for venipuncture to obtain blood samples. It is provided with a safety shield for covering the used venipuncture needle prior to disposal to aid in the prevention of needlestick injury if manually activated after the blood collection, the set also includes a blood collection holder for connection to vacuum-based collection vials.

The Subject Device is a sterile, single-use blood culture collection set. The blood collection set incorporates a venipuncture needle assembly that is connected with flexible tubing to a blood lock mechanism that is connected by flexible tubing to a blood collection holder. Blood collection is accomplished by inserting the venipuncture needle into the patient's peripheral vascular system. Blood will travel up the lumen into the blood lock mechanism where the initial draw of blood (approximately 0.15 ml) is held in a side chamber. The purpose of the side chamber is to automate the initial specimen diversion volume method (ISDVM). Once the side chamber volume is retained, the blood upon connection to a vacuum bottle continues to travel up the lumen to the blood collection holder into the attached blood culture bottle/vial. The Subject Device's venipuncture needle assembly incorporates an active, semi-automatic needlestick safety design where the safety mechanism is activated via a button on the needle hub. When the safety mechanism is activated, a protective shield is deployed. It advances distally to cover the entire length, including the distal tip, of the venipuncture needle. The protective shield is locked in this position protecting the clinician/patient from needlestick injuries. Silicone coating is applied to the outside of the venipuncture needle, which aids in the insertion into the peripheral vascular system. The Subject Device incorporates various blood collection holders to interact with various types of vacuum-based collection vials.

Intended to connect to short peripheral catheter to obtain initial blood draw and when disconnected from the blood collection portion of the device, the pressure-rated extension set is intended to be utilized with infusions systems to administer IV fluids, medications, blood products to the patient's vascular system and may be safety used with power injectors at pressures up to 325 psi.

The Subject device is a sterile, single-use device that consist of a pressure-rated extension set and the blood culture collection set. The blood culture collection set incorporates a luer connection, flexible tubing, blood lock mechanism, and blood collection holder. The pressure-rated extension set is connected to the blood collection set via the luer connection. The Subject device is provided to the healthcare facility in this configuration. The Peripheral IV (PIV) catheter is connected to the pressure-rated extension set via luer connection. Blood travels through the lumen of the Subject device into the blood lock mechanism where the initial draw of blood (approximately 1ml) is diverted and sequestered. The purpose of the sequestration is to automate the discard volume method (DVM). Once the sequestered volume is diverted and retained, the blood continues travel to the blood collection holder where the blood culture sample is obtained. Once the blood draw process is completed, the blood collection set of the Subject device is disconnected from the pressure-rated extension set and discarded. The pressure-rated extension set is utilized as an infusion system to administer IV fluids, medications, blood and blood products to the patient's vascular system. The pressure-rated extension set is rated to 325 PSI. Various blood collection holders are incorporated with the Subject device to interfaces with marketed blood culture bottles and vails. These blood collection holders are cleared under K912563 (Biomerieux Shield), K950432 (BD Vacutainer), and K081229 (Short Saf-T Holder). The blood collection holder incorporates a needle that is covered by elastomer boot. The culture bottle is inserted into the blood collection holder where the needle punctures the elastomer cap and provides a pathway for the blood to traveling into the culture bottle. The vacuum of the culture bottle pulls the blood. Once completed, the culture bottle is removed and the elastomer boot covers the needle and seals to fluid path.