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The Cure Catheter Insertion Kit is an intermittent urinary catheter kit indicated for the purpose of bladder drainage for males and females. The urinary catheter kit comes in a variety of configurations and sizes packaged sterile for single-use.

The Cure Catheter Insertion Kits (K1, K2, K2-90, K3), Cure Hydrophilic Catheter Kit (HMxxUK), Cure Pocket Catheter Kit (MxxUK), Cure Catheter Closed System Kit (CSxx)) contain sterile products used during intermittent urinary catheterization. Two types of kit are provided, one where a urinary catheter is included and one without a catheter. The components allow users to select one or more of the products to help prevent contamination of the environment and the user and to maintain a no-touch technique during the insertion of the catheter. Catheters are inserted through the urethra and indicated for the purpose of bladder drainage.

Flexi-Seal AIR™ (with ENFit™ Connector) is an indwelling fecal management catheter intended to manage fecal incontinence through the collection of liquid stool and to provide access to administer medications. The device is intended for use in adult patients.

The Flexi-Seal Air™ (supplied non-sterile) is comprised of a low pressure foam-filled 100% silicone rectal retention balloon fixed to the distal end of a soft collapsible silicone catheter tube with a labelled white inflation port and an auto Inflate valve, Luer lock inflation syringe, an ENFit connector for irrigation/medication port with an ENFit compatible syringe, cinch clamp, date formatted labels, a sub-assembled self-closing quick connector to the catheter end, a matching collection bag, and "Diamonds" gelling and odor control sachets (4 sachets per kit). The components are contained in a rigid thermoformed plastic clamshell.

Intermittent drainage of the urinary bladder of females who need assistance with drainage due to conditions causing urinary retention or dysfunction of the urinary system.

GentleCath Air for Women is a sterile, single use, disposable, hydrophilic, intermittent urethral catheter. A urethral catheter is a tubular device intended for being introduced into the urinary bladder through the urethra in order to provide drainage of the bladder. The catheter tube is made using Thermoplastic Elastomer (TPE) with a hydrophilic additive in the base material which when wetted activates and lubricates the catheter. GentleCath Air for Women is designed for portability, ease of use and discreet disposal. Catheters are individually packed and are wetted ready for use upon removal from the case. Catheters are available in the following product sizes: CH10, 12, and 14.

The Cure Dextra® Closed System is an intermittent urinary catheter attached to a collection bag that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females. The urinary catheter comes in a variety of sizes and is packaged sterile for single-use. The Cure Catheter® Closed System is an intermittent urinary catheter attached to a collection bag that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females. The urinary catheter comes in a variety of sizes and is packaged sterile for single-use.

The Cure Dextra® and Cure Catheter® Closed System catheters are intermittent urinary catheters intended to be used by males and females for the purpose of bladder drainage. They are manufactured with conventional medical grade, biocompatible materials that are not made with natural rubber latex. The tip has been designed to minimize trauma to the urethra and is provided in various sizes in easy-to-open, sterile, single-use packages. The subject devices are pre-lubricated catheter systems that allow for patient convenience when catheterization is required. The Closed System catheter is attached to a collection bag and features polished eyelets on a straight or Coudé catheter tip. The Dextra catheter will advance from the bag with every forward stroke while the rearward strokes allow for the mechanism to get a new grip on the catheter. The urine collection bag of the Dextra catheter is reduced from 1500 ml in the predicate Closed System to 1000 ml to make it compact and portable.

The Cure Ultra® is an intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females. The urinary catheter comes in a variety of sizes and is packaged sterile for single-use.

The Cure Ultra® catheters, which include the Cure Ultra® Male, Cure Ultra® Female and Cure Ultra® Plus products are intermittent urinary catheters intended to be used by males and females for the purpose of bladder drainage. They are manufactured with conventional medical grade, biocompatible materials that are not made with natural rubber latex. The tip has been designed to eliminate trauma to the urethra and is provided in various sizes in easy-to-open, sterile, single-use packages.

Intermittent drainage of the urinary bladder of Adults who need assistance with drainage due to conditions causing urinary retention or dysfunction of the urinary system. The target population for GC Air for Men is male adults and includes Transitional Adolescents B (18 year old to less than 22 years old but treated like adult).

GC Air for Men is a sterile, single use, disposable, hydrophilic, intermittent, urethral catheter. It is designed for portability, ease of use and discreet disposal, with FeelClean™ technology for superior comfort and less sticky residue. The catheter comprises of a flexible tube and color-coded funnel, both made from plastic materials (Polyvinyl Chloride; PVC). The catheter tube is made using thermoplastic elastomer (TPE) with a hydrophilic additive in the base material which when wetted activates and lubricates the catheter. Catheters are individually packed into a sealed foil primary pouch along with a sterile (E-Beam) water sachet and handling sleeve, prior to secondary and tertiary packing and sterilization by X-Ray irradiation. The water sachet is provided for wetting of the hydrophilic surface and is burst at the point of use. The handling sleeve is provided to minimize touching the catheter shaft directly during insertion and retraction.

The Flexi-Seal™ PROTECT PLUS Fecal Management System (with ENFit™ connector) is an indwelling fecal management catheter intended for use to manage fecal incontinence through the collection of liquid stool and to provide access to administer medications. The device is intended for use in adult patients.

The subject device, Flexi-Seal™ PROTECT PLUS Fecal Management System (with ENFit™ connector), has the same intended use as the predicate device (K162906). Both devices include a low-profile retention balloon, a finger pocket to allow for easy balloon insertion, a green dome to indicate the optimal fill status of the retention balloon, a red dome to indicate the over inflation status, and the ability to administer medication through the use of a cinch clamp. In addition, the subject device incorporates new features, including: add a self-closing ENFit port for irrigation/medication and provide an ENFit (1) syringe in the kit, (2) add a sub-assembled self-closing quick connector to the catheter end, and add a matching bag connector in the collection bag with an option of (3) incorporating Diamonds™ gelling and odor control sachet (4 sachets per kit) to solidify and deodorize the fecal contents in the collection bag.

The Avelle™ NPWT System is indicated for use on patients that would benefit from a Negative Pressure Wound Therapy (NPWT) device as it may promote wound healing via removal of exudate and infectious materials from low to moderately exuding wound, such as: - · Chronic Wounds e.g. Leg ulcers - · Acute Wounds - · Subacute and dehisced wounds - Traumatic wounds - · Flaps & Grafts - · Surgically closed incision sites Avelle™ NPWT System is suitable for use in a hospital, post-acute and home health environment.

The Avelle Negative Pressure Wound Therapy (NPWT) System consists of: - a disposable battery powered pump - absorbent wound dressing which is connected to the pump via tubing and luer-lock fittings - adhesive fixation strips The Avelle System is intended for single-patient use. The Avelle pump is disposable, portable and battery-powered. The internal software of the pump limits the use to 30 days. The pump requires 3 AAA lithium batteries to operate. Testing shows that the 3 batteries will power the pump for a minimum of 15.6 days based on testing. A total of 6 AAA lithium batteries (2 sets) are provided with the pump which will power the device for its entire 30-day lifetime. The disposable battery-powered pump unit is attached to the dressing via the supplied tubing and luer-lock fittings. The Avelle dressing is comprised of gelling fiber (Hydrofiber®) to absorb wound exudate with negative pressure applied indirectly to the dressing via the Avelle pump. The dressing is applied to the wound and secured around its periphery via its adhesive border and adhesive fixation strips are applied to ensure an adequate seal. The dressing's adhesive surface is protected by a split release liner system comprising of 2 or 3 sections of Low Density Polyethylene (LDPE) release liner (depending on dressing size), which are removed prior to dressing application. The pump is turned on to apply and maintain a nominal negative pressure of -80mmHg to the dressing. The pump will draw excess wound exudate and infectious materials away from the wound bed and into the Hydrofiber® layers as demonstrated in a simulated use test with a moderately exuding flow of 82 mL over 3 days and a second simulated use test with a low exuding flow of 102 mL over 7 days. The system will deliver up to 30 days' single patient use for the pump component, and up to 7 days' wear time for the dressing. Each dressing may be used for up to 7 days but may require more frequent changes due to clinical situations. After 30 days of use the pump must be discarded and treatment must be stopped. The pump unit is provided non-sterile. The Absorbing Dressing (with adhesive fixation strips) is provided sterile via ethylene oxide (EtO) sterilization.