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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: Cutaquig®, Immune Globulin Subcutaneous (Human) 16.5% Solution (manufactured by Octapharma®); 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 Xembify®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by Grifols®) in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling. The FREEDOM Integrated Syringe Infusion System with the FREEDOM60® 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 Freedom Integrated Syringe Infusion System consists of the following components: - FREEDOM60® Syringe Driver - Precision Flow Rate Tubing™M - 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: Cutaquig®, Immune Globulin Subcutaneous (Human) 16.5% Solution (manufactured by Octapharma®); Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®); and Xembify®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®). The FREEDOM60® Syringe Driver is indicated for use with the BD® 50 ml syringe (US Reference number 309653).

The FREEDOM® Integrated Syringe Infusion System is a single-channel, volumetric infusion pump. The FREEDOM60® Integrated Syringe Infusion System consists of four primary components: - 1. FREEDOM60® 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. FREEDOM60® Syringe Driver: The FREEDOM60® Syringe Driver in combination with Precision Flow Rate Tubing™ (sterile) and HIgH-Flo Subcutaneous Safety Needle Sets (sterile) makes up the Freedom Integrated Syringe Infusion system. The FREEDOM60® Syringe Driver is a non- sterile, reusable non-electric driver that infuses immunoglobulins subcutaneously and antibiotic solutions intravenously to patients. The FREEDOM60® Syringe Driver is an ambulatory device designed to accommodate a BD Luer- Lok™ 50mL Syringe (Catalog No.: 8881-560125, BD 309653), and fluid volumes ranging from 10cc to 60cc may be used. The pump uses a constant force spring mechanism to apply pressure to the plunger-end syringe. The Freedom Integrated Syringe System is assembled by loading the syringe with tubing into the Freemdom60® driver. 2. Precision Flow Rate Tubing™: 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. 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 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.

RMS High-FLO Super26™ Subcutaneous Needle Sets are indicated for subcutaneous infusion of medications in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling for the capacity for infusion of high flow rates including human plasma-derived immunoglobulins when used according to the FDA approved biologic labeling for: Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring); and Cuvitru™ Immune Globulin Infusion (Human) 20% (manufactured by Shire).

The RMS HIgH-Flo Super26™ Subcutaneous Needle Sets are sterile, non-pyrogenic, single use, Class II Subcutaneous Administration Set, per 21 CFR 880.5440, 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 90-degree, 26gauge 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 medic al grade tubing (Figure I). Additionally, each tubing set is equipped with a slide clamp used to stop flow, immediately; as needed. RMS HigH-Flo Super 26TM Subcutaneous Needle Sets are available as a single-needle set, as well as 2-needle, 4- needle, 5-needle, 6-needle sets; through use of a Y-connector, 7-needle and 8-needle sets may also be assembled. The device is for single use only.

The Integrated Catch-Up Freedom Syringe Driver Infusion System (ICFSDIS), which includes the FREEDOM60® and FreedomEdge® syringe pumps, is indicated for the intravenous infusion of medications and fluids in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling. The ICFSDIS is specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins when used according to the FDA approved biologic labeling: Hizentra, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring); Gammagard Liquid, Immune Globulin Infusion (Human) 10% (manufactured by Shire); and Cuvitry Immune Globulin Infusion (Human) 20% (manufactured by Shire). The ICFSDIS is specifically indicated for the intravenous infusion of the following antibiotics when used according to the FDA approved drug product labeling: meropenem, ertapenem, oxacillin, and tobramycin. The FreedomEdge® Syringe Infusion System is indicated for use with the BD 20 ml (model no. 302830/301031) or BD 30 ml (model no. 30103) syringe. The Freedom60 Syringe Infusion System is indicated for use with the BD 60 ml syringe (model no. 309653).

- 1. Freedom60® Syringe Driver: The Freedom60 Syringe Infusion driver in combination with RMS Freedom60 Precision Flow Rate Tubing™ (sterile) and RMS HIgH-Flo Subcutaneous Safety Needle Sets (sterile) makes up the Freedom60 infusion system. The Freedom60® driver is a non-sterile, reusable non-electric driver that infuses immunoglobulins subcutaneously and antibiotic solutions intravenously to patients. The Freedom60® driver is an ambulatory device designed to accommodate a BD Luer-Lok™ 60mL Syringe (Catalog No.: 8881-560125, BD 309653), and fluid volumes ranging from 10cc to 60cc may be used. The pump uses a constant force spring mechanism to apply pressure to the plunger-end svringe. The Freedom60 system is assembled by loading the prefilled syringe with tubing into the Freemdom60 driver. - 2. FreedomEdge® Syringe Driver: The FreedomEdge® Syringe Infusion driver is used with a syringe in an infusion system for administering therapeutic fluids. The infusion system or related kits can include, in addition to the pump assembly, a luer connector or disc luer connector for connecting the syringe to components of the infusion system, an RMS Precision Flow Rate Tubing™ (sterile) and RMS HIgH-Flo Subcutaneous Safety Needle Sets (sterile) for administering the therapeutic fluid subcutaneously into a patient's body. The FreedomEdge® driver is a portable device designed to accommodate BD Luer-Lok™ 20mL syringe, Catalog No.: 302830 and 301031 or BD Luer-Lok™ 30mL, Catalog No.: 301033. The pump uses a constant force spring mechanism to apply pressure to the plunger- end syringe. The FreedomEdge® is comprised of housing that has a distal end and a proximal end. The housing comprises an expandable base with a first base section and a second base section. wherein the first base section is in sliding engagement with the second base section such that the first base section and the second base section move relative to each other between a closed position and an expanded position. The base in the expanded position is adapted to seat a syringe with the plunger. There is also an expandable cover consisting of a first cover section and a second cover section, wherein the first cover section is in sliding engagement with the second cover section. The cover is pivotally connected to the base at a position allowing the cover to open and close in a sliding motion of the second base section, which is relative to the first base section moving together. When the cover is in the closed position, a pusher is in sliding engagement with the base. The pusher is in position to contact the head of the plunger and a puller is in position with the sliding engagement of the base. There is a spring at the first end portion and a second end portion. The first end portion is connected to the puller, while the second end portion is connected to the pusher and a set of linkages pivotally coupled to the cover and the puller. The pivots of the linkages are located to move the puller towards the distal end when the cover is lowered and move the puller towards the proximal end when the cover is raised. Moving the puller towards the distal end by lowering the cover when the syringe is seated in the base causes the pusher to contact and exert force on the head of the plunger, thereby causing ejection of any fluid contents in the syringe barrel. - 3. Precision Flow Rate Tubing Set: The Freedom60 Infusion system includes a range of Freedom Precision Flow Rate Tubing™. 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. - 4. High-Flo Needles set: The HIgH-FloTM Subcutaneous Safety Needle Sets are used to administer drugs to the subcutaneous layers using small needles attached to the skin. Typical uses are to administer immunoglobulins and antibiotics and for such applications subcutaneous needles come in different lengths. Subcutaneous Safety Needle Sets comes in multiple configurations (single, double, tri, and quad). Needles are available in 4mm, 6mm, 9mm, 12mm 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 trapped between the wings after use.

RMS HigH-Flo™ Subcutaneous Safety Needle Sets are intended for the delivery of medication to the subcutaneous tissue.

The RMS HIgH-Flo™ Subcutaneous Safety Needle Sets are a Class II Intravascular Administration Set per 21 CFR 880.5440 and intended for the delivery of medication to the subcutaneous tissue. Each set consists of a sterile packaged kit including the infusion set and a commercially available adhesive dressing used to hold the device in place. The infusion set has a 90-degree stainless steel grade needle mounted to a butterfly assembly on one end, and a luer lock on the other end, connected by medical grade tubing. The needles are available in 24 and 26 gauges and in lengths of 4mm, 6mm, 12mm and 14mm. The 4mm and 14mm lengths are added for children and obese adult patients, respectively. The optional convenience 24" Extension Set is used to add length to a needle set when desired. There is a snap closure to safely capture the needle after use. This minimizes the potential for a needlestick injury. Each leg in a set is equipped with a slide clamp to stop flow immediately, if needed. The RMS HIgH-Flo™ Subcutaneous Safety Needle Sets are available for up to 8 infusion sites using our basic sets of one, two, three or four legs ganged together using a low residual "Y-Connector" (for example to achieve a 7 site infusion, a RMS 4 set will be ganged with a RMS 3 set using a Y-Connector). All needle sets, regardless of combination, are for single use only.

RMS Subcutaneous Needle Sets are intended for the delivery of medication to the subcutaneous tissue.

The RMS Subcutaneous Needle Set is a Class II Intravascular Administration Set per 21 CFR 880.5440 and intended for the delivery of medication to the subcutaneous tissue. Each set consists of a sterile packaged kit including the infusion set and a commercially available adhesive dressing used to hold the device in place. The infusion set has a 90-degree stainless steel needle mounted to a butterfly on one end, and a luer lock on the other end, connected by medical grade tubing. Each set is equipped with a slide clamp used to stop flow immediately, as well as a snap together capture arrangement used to close the set upon completion. RMS Subcutaneous Needle Sets are available as single sets, as well as 2-needle, 3-needle, 4-needle, 5-needle and 6-needle assemblies, with the use of a low residual volume Y or multi-connector. The device is for single use only.

The RESTORE Vacuum Erection Device consists of two main parts: the vacuum pump and constriction ring. Intended use statements for these are as follows. Vacuum Pump (intended use) - used to create an erection in men with erectile dysfunction by means of an applied vacuum to the penis, which draws blood into the penile corpora cavernosa causing the penis to become erect and rigid. Constriction Ring (intended use) - used to maintain penile rigidity in men with erectile dysfunction by restricting penile venous outflow after the patient has obtained an erection with the aid of a vacuum pump.

The RESTORE Vacuum Erection Device consists of a vacuum pump, ABS plastic vacuum cylinder, connecting PVC tubing, cylinder end cap, cushion seal, constriction rings, a tube of personal water-based lubricant and a convenient travel case.