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The A-TAP is intended for use by healthcare professionals for general purpose fluid aspiration.

The A-TAP device is a fluid switching medical device consisting of a clear plastic barrel body, a sliding rod, two 6% female Luer lock connections, and one 6% male Luer lock connection. The internal surface of the device barrel body is lubricated with polydimethylsiloxane (silicone). The A-TAP is a single-use only, disposable, non-pyrogenic and sterilized by Gamma irradiation.

SafePort(TM) Manifold (or Stopcock) is a one or more multiple ports product, which is indicated to serve as a flow control and a conduit device for I.V fluids delivery to the patient's vascular system. The product is intended for delivering I.V drugs or fluids, allowing gravity feed, sampling, transfusion, bolus injection and elimination of reflux of fluids during operation.

Elcam modified SafePort™ Manifold (also identified as SafePort™ Manifold) is used in Operating Room (OR) and Intensive Care Unit (ICU) to assist the physician and mainly the anesthesiologist in delivering IV drugs and fluids during and after operation. Elcam's SafePort™ Manifold is designated for single use only (disposable) and its recommended maximal use duration is up to 24 hours. Liquid compatibility: Elcam's SafePort™ Manifold is compatible with common fluids used in I.V. therapy, anesthesia and monitoring, including blood transfusion. The SafePort™ Manifold is made of a body with 1-5 side ports and 1-5 handles (depends on the number of ports). Each port has a male or female connector (luer). Male connectors also include a nut (rotator) for locking over the female luer of the connected component. A small amount of lubricant is applied on the handle stem before placing it in the Stopcock/Manifold body. Operating mechanism is manual and simple operated by twisting the handle position to determine fluid direction. Between each handle and port housing an Elastomer may be placed to function as a pressure Luer Activated Valve (LAV) as an option to standard open female luer. The LAV is welded to the manifold body's fluid line at the female side port(s) in order to avoid back flow (reflux) and to serve as closed port. A rotator is assembled on the proximal male port (which is connected toward the patient) in order to enable connection locking. The distal female port is connected to the I.V Set to accept the delivered drug or fluid. Open ports (female and male) may be provided with or without covers. Design wise, the modified SafePort™ Manifold relies on Elcam legally marketed SafePort™ Manifold cleared under K111016 that was modified as follow: The SafePort™ Handle was modified for better producibility: Elastomeric material was changed, a cone-shape was added to the handle stem at the sealing area, as well as "door" shape fluid entrance added instead of around the entire stem. Cosmetic/visual non-functional changes were also implemented. The SafePort™ Body was changed to fit the handle changes: The stopper, dimensions luer compliance with ISO 80369-7, side port LAV female thread connection improvements and cosmetic/visual changes. Additional green colorant was added to the existing Caps' colorants. Transfusion use was added to the SafePort™ indications for use statement to align Elcam SafePort™ with all other Stopcock and Manifold products (as in the primary predicate device cleared under K060231) that share the same indications for use, basic fluid path design and material types. Labeling materials were revised to include the additional transfusion claim. All modifications were evaluated using well-established tests' methods previously utilized by Elcam or conducted per FDA recognized consensus standards and provided as summary tabulated in a risk analysis format.

Elcam Stopcocks and Manifolds are indicated for fluid flow directional control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.

Elcam Stopcocks and Manifolds (*including MRVLS, Closed Stopcock and S2R)

Elcam Stopcocks and Manifolds with Safe2 Rotator are indicated for fluid flow directional control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.

Elcam Stopcocks and Manifolds with Safe2 Rotator are an additional variation in the Elcam's Stopcocks and Manifolds product-family. The Safe2 Rotator component is male luer with a mounted and internally threaded rotator that is fixed on the stopcocks body with a modified male connector. Both components create a uniform straight fluid path. The device uniqueness is that the Safe2 Rotator can freely rotate on the stopcock male connector axis preventing the formation of kinks and twists in the IV sets during or following manipulations. In addition, the rotation ability of the Safe2 Rotator provides health care providers with a convenient access to a stopcock side (vertical) port during injection and aspiration.

The Y-Click Connector is a Y-connector Hemostatic Valve, which is intended to maintain hemostasis during the introduction, use and withdrawal of diagnostic and interventional devices used in angioplasty procedures such as; guide catheters, guide wires, balloons and stents. It is compatible with 9 Fr or smaller guide catheters and 0.014" -- 0.038" diameter guide wires.

The Y-Click connector is an accessory that can be connected, by a standard male luer-lock, to any standard Angiographic catheter, up to 9 Fr guiding catheters. The device has a septum that prevents blood loss. Common guide-wires (in diameter of 0.014" to 0.038") can be introduced via the device (through the slit septum) without bleeding due to the intra-catheter human arterial pressure. The septum can be opened to an unsealed position in order to enable introducing of various angioplasty devices (such as; balloons and stents). Unlike similar devices, The Y-Click can also be opened to a semi unsealed position. The semi unsealed position reduces the friction during catheter manipulation and makes the device more ergonomic and easy to use. The septum is opened to a semi unsealed position by one push of the cover (a "click" is heard). Pushing the cover twice (two "clicks" are heard) opens the device to an unsealed position (full open position). In order to return to a closed position, the Y-Click's lever should be pressed once. A "click" is heard and the device returns to a closed position. The injection of contrast media, saline flush and blood pressure monitoring can be performed through the Y side arm.

Elcan Induction & Sampling Manifold for Stopcock] is a one or multiple ports product, which is indicated to serve as a flow control and a conduit device for I.V fluids delivery to the patient's vascular system. The product is intended for delivering I.V drugs or fluids, allowing gravity feed, sampling, bolus injection and elimination of reflux of fluids during operation.

Elcam I&S Manifold is composed of a body that fits for number of ports assembly (by bonding) and handles which are assembled into the ports bodies. Between each handle and port body an Elastomer is placed to function as a pressure activated valve. A small amount of UV Adhesive is applied in order to bond the product body to the female side ports. A check valve is assembled to the product body end (which is connected to the I.V Set) in order to eliminate back flow (reflux). A Rotor is assembled to the male luer (which is connected toward the patient) in order to enable connection locking. A small amount of lubricant is applied between the Elastomer and the port body. Same concept can be available for one single Stopcock (single I&S Stopcock will not include Check Valve unless otherwise required by end user). Elcam I&S Manifold will be available in a wide variety of configurations for use according to particular situation and the clinician's preference.