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510(k) Data Aggregation
(139 days)
SURFLO Hybria Closed System Safety IV Catheter is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. The device may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. When the device is used with a power injector, the needle-free connector should be removed, and the maximum pressure limit is 325 psi (2.24MPa).
SURFLO Hybria Closed System Safety IV Catheter is an over-the-needle intravascular catheter. It primarily includes a catheter, a 3D-Shin™ needle with a safety shield, double wings, an extension tube, a luer adapter, vent fitting(s), and a pre-attached SURPLUG™ AD needle-free connector (for some configurations).
The double wings of the SURFLO Hybria Closed System Safety IV Catheter can be folded and pinched together for puncture and catheter advancement. The distance from the grip position to the needle tip is short, which facilitates vascular puncture. The 3D-Shin™ needle features an engineered three-dimensional geometry of the needle tip. The needle tip is completely covered by the safety shield when it is withdrawn after visualization of blood return, which minimizes the risk of accidental needlestick injury. The closed design can prevent blood leakage throughout the entire puncture process.
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