(187 days)
Flushing of IV catheters and IV tubing only. Prior to and after administration of intermittent medication, entirely flush the catheter and or tubing with Heparin Lock Flush Solution, either USP 10 Units/mL or USP 100 Units/mL. Use in accordance with any warning or precautions appropriate to medication being administered. This device is not to be used for anticoagulant therapy.
Syrex Pre-Filled Syringe, Heparin Lock Flush Solution, USP 10 and 100 Units/ml
This document is a 510(k) clearance letter for a medical device, the Syrex Pre-Filled Syringe, Heparin Lock Flush Solution. It is a regulatory approval document and does not contain information about acceptance criteria, device performance studies, or clinical trial data as typically found in a scientific study or clinical report.
Therefore, I cannot provide the requested information based on the input text. The input text primarily deals with:
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- Confirmation of substantial equivalence to a predicate device.
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- Indications for Use statement for the device.
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§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).