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The SV Spectrum MRC Central Venous Catheter is indicated to provide short-term (<30 days) central venous access intended for: - Continuous or intermittent drug infusion - Central venous blood pressure monitoring (CVP) - Acute hyperalimentation - Blood sampling - Delivery of whole blood or blood products - Simultaneous, separate infusion of drugs - Power injection of contrast media (max 300 psi) The activity of the antimicrobial agents, minocycline, rifampin and chlorhexidine is located at the internal and external catheter surfaces and is not intended for treatment of existing infections. This combination of antimicrobials has been shown to reduce microbial colonization of the catheter. The effectiveness was evaluated using in vitro methods; no correlation between in vitro and clinical outcome has currently been ascertained. Controlled studies of this product have not been conducted in pregnant women, pediatic or neonatal patients. The use of this catheter should be weighed against any possible risk. Consider CDC Guidelines and institutional protocols for catheter exchange. The SV Spectrum MR Central Venous Catheter is indicated to provide short-term (<30 days) central venous access intended for: - Continuous or intermittent drug infusion - Central venous blood pressure monitoring (CVP) - Acute hyperalimentation - Blood sampling - Delivery of whole blood or blood products - Simultaneous, separate infusion of drugs and - Power injection of contrast media (max 300 psi). The activity of the antimicrobial agents, minocycline and rifampin is localized at the internal catheter surfaces and helps to provide protection against catheter related bloodstream infections (CRBSI). It is not intended for treatment of existing infection. The device is a short- term use catheter. The SV Central Venous Catheter is indicated to provide short- term (<30 days) central venous access intended for: - Continuous or intermittent drug infusion - Central venous blood pressure monitoring (CVP) - Acute hyperalimentation - Blood sampling - Delivery of whole blood or blood products - Simultaneous, separate infusion of drugs and - Power injection of contrast media (max 300 psi).

The SV Spectrum MRC Central Venous Catheter (CVC) is a single-use, antibiotic impregnated, antimicrobial coated, power injectable catheter that is percutaneously inserted into the vasculature using the Seldinger technique, and advanced over a wire guide until its tip is positioned above the superior vena cava-right atrium (SVC-RA) junction within the lower third of the SVC. The SV Spectrum MRC Central Venous Catheter, 7 Fr triple lumen CVC, is made from an aliphatic polyether-based polyurethane catheter shaft with a radiopaque constituent and a bonded soft distal tip. The catheter shaft is impregnated with Spectrum® (minocycline, rifampin) antimicrobial agents and coated with chlorhexidine antiseptic. The SV Spectrum MRC Central Venous Catheter is not intended for treatment of existing infections in patients; the presence of the three antimicrobial agents has been shown to reduce microbial colonization of the catheter. The SV Spectrum MRC CVC has demonstrated efficacy against the following organisms: - Staphylococcus aureus - Staphylococcus epidermidis - Enterococcus faecalis - Escherichia coli - Klebsiella pneumoniae - Acinetobacter baumanni - Candida albicans - Candida glabrata The effectiveness was evaluated using in vitro methods. The antimicrobial activity of these agents is localized to the internal and external catheter surfaces. The working length (15, 20, or 25 cm) of the catheter is measured from distal tip to the double bar line approximately 1.5 cm distal to the manifold. The catheter shaft features centimeter length markings. The proximal portion of the SV Spectrum MRC Central Venous Catheter, like the predicate catheter, has three extension tubes with injection-molded Luer hubs connected to a manifold. The injection-molded manifold with suture wings serves as the transition point for lumens of the extension tubes into each lumen of the catheter shaft. All three lumens are power injectable; the maximum flow rate is labeled on the hub of each extension tube. The SV Spectrum MR Central Venous Catheter is identical to the SV Spectrum MRC Central Venous Catheter except that it is not coated with chlorohexidine antiseptic. The SV Central Venous Catheter is identical to the SV Spectrum MRC Central Venous Catheter and SV Spectrum MR Central Venous Catheter except it is not impregnated with minocycline or rifampin, nor is it coated with chlorhexidine antiseptic.