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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.

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.