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The FreedomEdge® Syringe Infusion System is intended for the intravenous or subcutaneous infusion of medications and fluids in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling. Intended population: adults and pediatrics. The FreedomEdge® Syringe Infusion System consists of the following components: - FreedomEdge® Syringe Driver - Precision Flow Rate Tubing™ - HIgH-Flo Subcutaneous Safety Needle Sets™ - HIgH-Flo Super26™ Subcutaneous Needle Sets are specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins: Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®) Single-use pre-filled syringe for subcutaneous administration. The FreedomEdge® Syringe Infusion System is indicated for use with the BD® 20 ml syringe (US Reference number: 302830), BD 30 ml syringe (US Reference number: 302832) and Hizentra® 20 ml prefilled syringe (NDC 44206-458-96). For Immunoglobulin Administration: The Freedom Integrated Syringe Infusion System is specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins when used according to the FDA approved biologic labeling: Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Gammagard Liquid®, Immune Globulin Infusion (Human) 10% (manufactured by Takeda®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®) and Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®) Single-use pre-filled syringe for subcutaneous administration in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling. For EMPAVELI™ (pegcetacoplan) Administration: The Freedom Integrated Syringe Infusion System is specifically indicated for the subcutaneous infusion with EMPAVELI™ (pegcetacoplan) in the home, hospital, or ambulatory setting when administered according to the approved drug product labeling. For Intravenous Antibiotic Administration: The Freedom Integrated Syringe Infusion System with the FreedomEdge® Syringe Driver and Precision Flow Rate Tubing™, is specifically indicated for the intravenous infusion of the following antibiotics when used according to the FDA approved drug product labeling: Ertapenem, Meropenem, Oxacillin, and Tobramycin.

The FreedomEdge® Syringe Infusion System is a single-channel, volumetric infusion pump. The FreedomEdge® Syringe Infusion System consists of four primary components: - 1. FreedomEdge® Syringe Driver, - 2. Precision Flow Rate Tubing™ and - 3. HIgH-Flo Subcutaneous Safety Needle Set™, or - 4. HIgH-Flo Super26TM Subcutaneous Safety Needle Set 1. FreedomEdge® Syringe Driver: The FreedomEdge® Syringe Driver (non-sterile) in combination with Precision Flow Rate Tubing™ (sterile) and HIgH-Flo Safety Needle Sets (sterile) makes up the FreedomEdge® Syringe Infusion System. The FreedomEdge® Syringe Driver is a nonsterile, reusable non-electric driver that infuses immunoglobulins and Pegcetacoplan subcutaneously and antibiotic solutions intravenously to patients. The FreedomEdge® driver is an ambulatory device designed to accommodate a BD Luer-Lok™ 20mL syringe. Catalog No.: 302830 and 301031. BD Luer-Lok™ 30mL syringe, Catalog No.: 301033 and Hizentra® 20 ml prefilled syringe. The pump uses a constant force spring mechanism to apply pressure to the plunger-end syringe. The FreedomEdge® Syringe Infusion System is assembled by loading the syringe with tubing into the FreedomEdge® driver. 2. Precision Flow Rate Tubing™: The FreedomEdge® Syringe Infusion System includes a range of Freedom Precision Flow Rate Tubing™ (provided sterile). The tubing ranges from F0.5 to F2400. Each Fnumber provides a different level of flow restriction, which, when combined with the viscosity of the medication, provides a controlled delivery in an all-mechanical system. The tubing sets connect at one end to the syringe being used and on the other end to the Subcutaneous Safety Needle Sets or directly on venous catheters for intravenous infusions as needed. 3. HIgH-Flo Needles Sets: The HIgH-Flo Subcutaneous Safety Needle Sets™ The HIgH-Flo Subcutaneous Safety Needle Sets™ (provided sterile) are used to administer drugs to the subcutaneous layers using small needles attached to the skin. Subcutaneous needles come in different lengths to administer immunoglobulins, pegcetacoplan, and antibiotics. Subcutaneous Safety Needle Sets come in multiple configurations (1, 2, 3, 4, 5, 6 needle sites). Needles are available in 4mm, 6mm, 9mm, 12mm, and 14mm lengths combined with 24 or 26 Gauge. Using the Y-Connector, the patient can have up to 8 sites for drug delivery. The HIgH- Flo Subcutaneous Safety Needle Sets™ also allow each needle to be enclosed between the wings after use. The HIgH-Flo Super26TM Subcutaneous Needle Sets The HIgH-Flo Super26TM Subcutaneous Needle Sets are sterile, non-pyrogenic, single use, Subcutaneous Administration Sets, comprised of a Super 26-gauge needle assembly, combined with 24-gauge needle tubing and are intended for the delivery of medication to the subcutaneous tissue. Each set consists of a sterile infusion set and a commercially available adhesive dressing used to hold the device in place. The infusion set is a 90degree, 26-gauge stainless steel needle, mounted to a butterfly winged safety closure on one end which is used to close the set upon completion. The other end consists of a luer lock which connects to PVC medical grade tubing. Additionally, each tubing set is equipped with a slide clamp used to stop flow, immediately as needed. HIgH-Flo Super 26TM Subcutaneous Needle Sets are available as a single set, as well as 2-needle, 3needle, 4-needle, 5-needle, 6-needle, sets; through use of a Y-connector, 7-needle and 8 needle sets may also be assembled.

The FreedomEdge® Syringe Infusion System is indicated for the intravenous or subcutaneous infusion of medications and fluids in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling. The FreedomEdge® Syringe Infusion System is specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins when used according to the FDA approved biologic labeling: Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Gammagard Liquid®, Immune Globulin Infusion (Human) 10% (manufactured by Takeda®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®) and Hizentra®. Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®) Single-use pre-filled syringe for subcutaneous administration. The FreedomEdge® Syringe Infusion System with the FreedomEdge® Syringe Driver and Precision Flow Rate Tubing™, is specifically indicated for the intravenous infusion of the following antibiotics when used according to the FDA approved drug product labeling: ertapenem, oxacillin, and tobramycin. The FreedomEdge® Syringe Infusion System consists of the following components: - FreedomEdge® Syringe Driver ● - Precision Flow Rate Tubing™ ● - HIgH-Flo Subcutaneous Safety Needle SetsTM ● - HIgH-Flo Super26™ Subcutaneous Needle Sets are specifically indicated for the subcutaneous infusion ● of the following human plasma-derived immunoglobulins: Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®) Single-use pre-filled syringe for subcutaneous administration. The FreedomEdge® Syringe Infusion System is indicated for use with the BD® 20 mL syringe (US Reference number: 302830), BD 30 mL syringe (US Reference number: 302832), and Hizentra® 20 mL single-use prefilled syringe (NDC 442096-458-96).

The FreedomEdge® Syringe Infusion System is a single-channel, volumetric infusion pump. The FreedomEdge® Syringe Infusion System consists of four primary components: - 1. FreedomEdge® Syringe Driver, - 2. Precision Flow Rate Tubing™ and - 3. HIgH-Flo Subcutaneous Safety Needle Set™, or - 4. HIgH-Flo Super26TM Subcutaneous Safety Needle Set FreedomEdge® Syringe Driver: 1. The FreedomEdge® Syringe Driver (non-sterile) in combination with Precision Flow Rate Tubing™ (sterile) and HIgH-Flo Safety Needle Sets (sterile) makes up the FreedomEdge® Syringe Infusion System. The FreedomEdge® Syringe Driver is a nonsterile, reusable non-electric driver that infuses certain immunoglobulins subcutaneously and antibiotic solutions intravenously to patients. The FreedomEdge® driver is an ambulatory device designed to accommodate a BD Luer-Lok™ 20mL syringe, Catalog No.: 302830 and 301031, BD Luer-Lok™ 30mL syringe. Catalog No.: 301033 and Hizentra® 20 ml prefilled syringe. The pump uses a constant force spring mechanism to apply pressure to the plunger-end syringe. The FreedomEdge® Syringe Infusion System is assembled by loading the syringe with tubing into the Freemdom60® driver. Precision Flow Rate Tubing™: 2. The Freedom Integrated Syringe System includes a range of Freedom Precision Flow Rate Tubing™ (provided sterile). The tubing ranges from F0.5 to F2400. Each F-number provides a different level of flow restriction, which, when combined with the viscosity of the medication, provides a controlled delivery in an all-mechanical system. The tubing sets connect at one end to the syringe being used and on the other end to the Subcutaneous Safety Needle Sets or directly on venous catheters for intravenous infusions as needed. 3. HIgH-Flo Needles Sets: The HIgH-Flo Subcutaneous Safety Needle SetsTM The HIgH-Flo Subcutaneous Safety Needle Sets™ (provided sterile) are used to administer drugs to the subcutaneous layers using small needles attached to the skin. Subcutaneous needles come in different lengths to administer immunoglobulins and antibiotics per the indications for use. Subcutaneous Safety Needle Sets comes in multiple configurations (1, 2, 3, 4, 5, 6 needle sites). Needles are available in 4mm. 6mm. 9mm. 12mm. and 14mm lengths combined with 24 or 26 Gauge. Using the Y -Connector, the patient can have up to 8 sites for drug delivery. The HIgH- Flo Subcutaneous Safety Needle Sets™ also allow each needle to be enclosed between the wings after use. The HIgH-Flo Super26TM Subcutaneous Needle Sets The HIgH-Flo Super26™ Subcutaneous Needle Sets are sterile, non-pyrogenic, single use. Subcutaneous Administration Sets, comprised of a Super 26-gauge needle assembly, combined with 24-gauge needle tubing and are intended for the delivery of medication to the subcutaneous tissue in accordance with the indication for use statement. Each set consists of a sterile infusion set and a commercially available adhesive dressing used to hold the device in place. The infusion set is a 90- degree, 26-gauge stainless steel needle, mounted to a butterfly winged safety closure on one end which is used to close the set upon completion. The other end consists of a luer lock which connects to PVC medical grade tubing. Additionally, each tubing set is equipped with a slide clamp used to stop flow, immediately as needed. HIgH-Flo Super 26™ Subcutaneous Needle Sets are available as a single set, as well as 2-needle, 3-needle, 5-needle, 6-needle, sets; through use of a Y-connector, 7-needle and 8 needle sets may also be assembled.