Search Results

The Medtronic Extended infusion set is indicated for subcutaneous infusion of medication administered by an external pump. The infusion set is indicated for single use.

The Medtronic Extended infusion set manufactured by Unomedical a/s is a sterile, non-pyrogenic, single use subcutaneous infusion set which includes a 90-degree soft cannula. It is delivered ready to use in a preloaded insertion device with automatic needle retraction. The product is indicated for subcutaneous infusion of medication administered by an external pump. The insertion needle and soft cannula of the Medtronic Extended infusion set are hidden from the user before, during and after insertion of the soft cannula. This feature helps prevent needle stick injuries as the device does not require loading with the needle by the user, the needle is then automatically retracted after use. The Medtronic Extended infusion set is designed to be used with a Medtronic Insulin infusion pump for up to 7 days.

The neria™ guard Infusion Set is indicated for subcutaneous infusion of medication administered by an external pump.

The neria™ guard Infusion Set manufactured by Unomedical is a sterile, non-pyrogenic, single use subcutaneous infusion set which includes a 90-degree soft cannula. It is delivered ready to use in a preloaded insertion device with automatic needle retraction. The product is indicated for subcutaneous infusion of medication. The insertion needle and soft cannula of the neria™ guard Infusion Set are hidden from the user before, during and after insertion of the soft cannula. This feature helps prevents needle stick injuries as the device does not require loading with the needle is then automatically retracted after use.

The MiniMed™ Mio™ Advance infusion set is indicated for subcutaneous infusion of medication administered by an external pump.

The MiniMed™ Mio™ Advance infusion set manufactured by Unomedical is a sterile, non-pyrogenic, single use subcutaneous infusion set which includes a 90-degree soft cannula. It is delivered ready to use in a pre-loaded insertion device with automatic needle retraction. The product is indicated for subcutaneous infusion of medication. The insertion needle and soft cannula of the MiniMed™ Mio™ Advance infusion set are hidden from the user before, during and after insertion of the soft cannula. This feature helps prevents needle stick injuries as the device does not require loading with the needle by the user, the needle is then automatically retracted after use. The MiniMed™ Mio™ Advance infusion set will include a 27-gauge introducer needle, and will be available in two different soft cannula lengths of 6 and 9mm and three different tubing lengths of 46, 60 and 110cm. The tube set is available in P-Cap assembly or luer lock. The MiniMed™ Mio™ Advance infusion set has been updated from the predicate K032854 Unomedical Inset ''M Subcutaneous Infusion Set by the same manufacturer. The only modifications were made to the inserter component and include a single molded component rather than two pieces, and the addition of a needle safety shield. The connector and tubing of the tubing set remains unchanged.

The Unomedical Comfort™ Subcutaneous Infusion Set and Unomedical Comfort Short™ Subcutaneous Infusion Set are indicated for subcutaneous infusion of insulin administered by an external pump. The Unomedical Neria Soft Subcutaneous Infusion Set is indicated for subcutaneous infusion of medication administered by an external pump. The Medtronic Silhouette® Subcutaneous (Luer Lock) Infusion Set is indicated for subcutaneous infusion of insulin from and infusion pump. The Medtronic Silhouette Paradigm® Subcutaneous Infusion Set is indicated for use with Medtronic Paradigm Insulin Subcutaneous Infusion Pumps for continuous subcutaneous insulin infusion by patients or caregivers in the home environment. The Roche Accu-Chek Tender™ Subcutaneous Infusion Set is indicated for subcutaneous infusion of insulin administered with microdosage insulin pumps. The Asante Comfort™ Subcutaneous Infusion Set is indicated for subcutaneous infusion of insulin administered by the Snap™ Insulin Pump System. The Abbott Comfort™ Subcutaneous Infusion Set is indicated for infusion of fluids into the body below the surface of the skin when attached to a fluid reservoir of a compatible Abbott pump.

The Comfort Subcutaneous Infusion Sets are sterile, non-pyrogenic, single use subcutaneous infusion sets. The current sets are designed to be used with commercially available infusion devices or are indicated for a specific pump where the set has a proprietary pump reservoir connection (e.g. Medtronic, Asante). Each has two basic components provided for each device. The first is a stand-alone subcutaneous indwelling Soft Cannula. This component of the set is provided as an integral assembly with a PFOA-Free PTFE soft cannula, adhesive backed fixation tape, an injection port and the female portion of a proprietary plastic "click-lock" connector. The assembly comes with a stainless-steel insertion needle. The insertion needle is mounted to a male portion of the proprietary plastic "click-lock" connector. The insertion needle comes to the user inserted through the injection port and the inner lumen of the soft cannula with the needle end protruding past the tip of the soft cannula. The male connector is locked to the female connector on the indwelling soft cannula. A needle protector is assembled over the soft cannula and the insertion needle. A separate male portion of the proprietary connector without the insertion needle is provided in the package. This component is used to attach to the female connector after the indwelling soft cannula has been inserted and the steel insertion needle has been withdrawn and protects the indwelling cannula when the infusion set is not attached. Each Soft cannula set comes individually packaged in its own blister pack sealed with paper lid stock. The second component is the infusion tubing set. The infusion tubing set for all sets are comprised of a co-extruded tube with a stainless-steel needle incorporated into the male portion of the proprietary plastic "click-lock" connector at the patient end. The proximal end of the current Comfort set terminates in either a standard luer lock connector or a proprietary connector compatible with the specified pump. The sets come individually packaged in blister packs sealed with paper lid stock.

These sets are intended to be used with Medtronic Paradigm Insulin Subcutaneous Infusion Pumps for continuous subcutaneous insulin infusion by patients or caregivers in the home environment.

All of the Subcutaneous Insulin Infusion Sets are sterile, non-pyrogenic, single use subcutaneous infusion sets. Each set design has two main components provided for each device. The first is a subcutaneous indwelling Cannula component and the second is a tubing set component. For all sets, the connection of the indwelling cannula to the tubing set is made using a proprietary plastic "click-lock" connector system that enables the disconnection. The Cannula component has an adhesive backed fixation tape that is attached directly to the patient's skin over the injection site. The cannula is sometimes provided separately from, and sometimes provided pre-attached to the tubinq, but in all cases is able to be detached from the tubing to temporarily discontinue the infusion or to replace the cannula independent of the tubing. Some of the cannulas are stainless steel needles and others are soft catheters that are inserted with stainless steel insertion needles that are then removed and discarded. All except the Mio® are manually inserted into the subcutaneous tissue. The Mio® is provided integrated in an automated inserter. The second main component of the set is the tubing set. The infusion set tubing for all sets, except for the QuickSet, are comprised of a co-extruded tube with a stainless steel needle incorporated into the male portion of the proprietary plastic "click-lock" connector at the patient that punctures and penetrates a septum in the cannula connector, creating an aseptic fluid path to the user and that enables the connection and disconnection. The QuickSet tubing connects and disconnects with a snap on connection to the cannula component. The sets are offered in different lengths of tubing. As these sets are specifically designed only to be used with the commercially available MiniMed Paradigm Insulin Infusion pumps which use a MiniMed Paradigm medication reservoir with a proprietary pump reservoir connection, all of these sets terminate at the proximal end with the P-Cap connector. The P-Cap connector has a stainless steel needle that punctures and penetrates the insulin cartridge, creating an aseptic fluid path to the user. The P-Cap also attaches to the pump housing creating a water tight interface between the pump housing and the P-Cap, precluding water ingress into the pump through the cartridge reservoir chamber. Once sealed onto the pump, the hydrophobic membrane in the P-Cap enables pressure equalization between the inside of the pump (external to the drug reservoir) and the external environment under all ambient pressure conditions. This venting mechanism is designed to allow equalization of a pressure differential created by an altitude change between sea level and 10,000 feet air within 10 minutes, will withstand 8 feet of water for 30 minutes, and have a dry out time of 10 minutes or less. All of the subject sets are identical to the predicate sets in design, materials, manufacture, user interface, labeling, indications for use and intended use except for the material of the P-Cap Membrane.

The neria™ soft 90 infusion set is Indicated for subcutaneous infusion of medication administered by an external pump.

The neria™ soft 90 subcutaneous infusion set is a new product designed by Unomedical based on the Unomedical Inset™ Subcutaneous Infusion Set and Unomedical Quick-Set® Subcutaneous Infusion Set. The neria™ soft 90 is a 90 degree soft cannula infusion set with a standard luer-lock connection. The neria™ soft 90 subcutaneous infusion set consists of an introducer needle/insertion handle that inserts the soft cannula into the skin and is removed immediately after insertion, a cannula housing that rests upon the skin with adhesive tape, securing the soft cannula in place under the skin, tubing with disconnect option and a reservoir connector (standard luer lock) and disconnect cover for the tubing and cannula housing. The proposed configurations are: - includes tubing and cannula . Infusion Set - Tubing Only ● - . Cannula only

These infusion sets are indicated for the subcutaneous infusion of medication from an external Infusion Pump.

The asante comfort™ Subcutaneous Infusion Sets for use with the Asante Pearl™ pump and the currently marketed Comfort™ Subcutaneous Infusion Sets are both sterile, non-pyrogenic, single use subcutaneous infusion sets. For the connection to the infusion set, the current Comfort™ sets have a standard female luer connector compatible with many commercially available infusion devices while the new asante comfort™ sets have the unique connector/adapter only compatible with the Asante Insulin Infusion Pump cleared as part of the Asante Pearl™ Diabetes Management System 510(k), file number K100567. This connector/adapter is provided to Unomedical as a finished, tested component by Asante Solutions, the manufacturer of the Asante Pump, and is bonded,us ing the same adhesive, to the pump end of a standard Comfort™ infusion set in lieu of the female luer by Unomedical. The remainder of the set, including all fluid contact materials, sterile packaging, and the manufacturing and sterilization process are unchanged. The method of use of the devices is the same as for the unmodified devices including attaching the connector end of the set to the pump per the pump manufacturers' instructions and the use of the pump with the Comfort™ Subcutaneous Infusion Sets were included as part of the Asante 510(k) file. The asante conset™ Subcutaneous Infusion Sets for use with the Asante Pearl™ pump and the current Inset™ Subcutaneous infusion Sets are both sterile, nonpyrogenic, single use subcutaneous infusion sets with an integrated springpowered catheter insertion device. For the connection to the infusion set, the current Inset™ infusion sets have a standard luer connector compatible with commercially available infusion devices while the new Asante Conset™ sets have a unique connector/adapter compatible with the Asante Pearl™ Infusion Pump cleared as part of the Asante Pearl™ Diabetes Management System 510(k), file number K100567. This part is provided to Unomedical as a finished, tested component by Asante Solutions, the manufacturer of the Asante Pump, and is bonded, using the same adhesive, to the pump end of a standard Inset™ infusion set in lieu of the female luer by Unomedical. The remainder of the set, including all fluid contact materials, sterile packaging, and the manufacturing and sterilization process are unchanged. The method of use of the devices is the same as for the unmodified devices including attaching the connector end of the set to the pump per the pump manufacturers' instructions and the use of the pump with the Inset™ Subcutaneous Infusion Sets were included as part of the Asante 510(k) file.

The i-port Advance™ injection port is indicated for patients who administer, or to whom is administered, multiple daily subcutaneous injections of physician prescribed medications, including insulin. The device may remain in place for up to 72 hours to accommodate multiple drug injections without the discomfort of additional needle sticks. The i-port Advance™ may be used on a wide range of patients, including adults and children. Model numbers for the device include 020110, 020210, 020102 and 020202.

The i-port Advance™ injection port was designed and developed through a technological collaboration between Unomedical A/S and Patton Medical Devices and modifies the Patton Medical Device i-port@ injection port (K052389) to include the automated insertion component ("Inserter") of the Unomedical Inset™ Infusion Sct (K032854). The Injection Port component is a prescription only, sterile, single use, non-pyrogenic, external, disposable injection port with an indwelling catheter through which physician-prescribed medications can be injected subcutaneously from a standard syringe and needle, pen or alternative manual injection device. The indwelling catheter is installed using the integrated Inserter, a manually-operated springloaded catheter insertion tool that introduces the indwelling catheter into the subcutaneous tissue by automatically inserting the prefixed introducer needle to a predetermined depth below the skin surface. Once applied, the insertion needle is removed, and only the soft cannula remains under the skin, acting as a gateway to the subcutaneous tissue. The user injects medicines directly through the resealable septum at the top of the device. The needle of the syringe or insulin pen remains above the surface of the skin, while the medication is delivered through the soft cannula and into the subcutaneous tissue. The device, which may be worn for up to 72 hours and receive up to 75 injections, is designed to reduce the hardships of multiple daily subcutaneous injections.

These sets are indicated for the subcutaneous infusion of medication, including insulin from compatible infusion pumps.

Not Found

These sets are indicated for the infusion of fluids into the body below the surface of the skin when attached to a fluid reservoir.

Not Found