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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.

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.

Intermittent Catheters are indicated for routine transient intermittent drainage of the bladder. The cather is inserted through the urethra.

A hydrophilic urological catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids from the bladder. The tip/distal end of the tube are inserted into the urethra and the funnel/connector end is used to drain the urine or can be connected to a urine drainage bag. The device is made using Polyolefin Based Synthetic Thermoplastic Elastomer (TPE) as base material with the addition of an additive material is hydrophilic and makes the surface slippery when wetted with water. The products are designed for transient use only and are available in male and female lengths. The products are available in various diameters; Six FR/CH sizes: CH08, CH10, CH12, CH14, CH16, CH18. An increasing Charrière corresponds to a larger external diameter. The male catheter range also consists of variants with a bent (Tiemann) catheter tip shape.

For Over-the-Counter Use: AQUACELTM Ag+ EXTRA Enhanced Hydrofiber™ Dressing with Silver and Strengthening Fiber may be used for the management of: Abrasions, Lacerations, Minor cuts, Minor scalds and burns. Under the supervision of a healthcare professional: AQUACEL™ Ag+ EXTRA Enhanced Hydrofiber™ Dressing with Silver and Strengthening Fiber may be used for the management of: Wounds as an effective barrier to bacterial penetration of the dressing as this may help reduce infection; Partial thickness (second degree) burns; Diabetic foot ulcers, leg ulcers, (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) and pressure ulcers/sores (partial & full thickness); Surgical wounds left to heal by secondary intention such as dehisced surgical incisions; Surgical wounds that heal by primary intent such as dermatological and surgical incisions (e.g., orthopedic and vascular); Traumatic wounds; Wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided and donor sites; Oncology wounds with exudate, such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma, and angiosarcoma; Management of painful wounds; Infected wounds.

AQUACEL™ Ag+ EXTRA™ Enhanced Hydrofiber™ dressing with Silver and Strengthening Fiber is a soft, sterile dressing made from two layers of 1.2% ionic silver impregnated sodium carboxymethylcellulose fiber with added Ethylenediaminetetraacetic Acid Disodium Salt (EDTA) and Benzethonium Chloride and stitched together with strengthening fibers. The two Hydrofiber™ layers are nominally 77gsm (grams per square meter) weight each. Aquacel Ag+ also includes added Ethylenediaminetetraacetic Acid Disodium Salt (EDTA) and Benzethonium Chloride (BECL).

Intermittent Catheters are indicated for routine short term drainage of the bladder. The catheter is inserted through the urethra.

The GentleCath™ Intermittent Urinary Catheter is labelled as a single use, sterile device and is sterilized by Ethylene Oxide to a Sterility Assurance Level of 10-6 A urological catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids from the bladder. tip/distal end of the tube is inserted into the urethra and the funnel/connector end is used to drain the urine or can be connected to a urine drainage bag. Both components of the device are made using Polyvinyl chloride (PVC) as base material and bonded with Cyclohexanone. The products are designed for transient use only and are available in various diameters; Six FR/CH sizes: CH08, CH10, CH12, CH16, CH18. An increasing Charrière corresponds to a larger external diameter.

Intermittent catheters are indicated for routine transient intermittent drainage of the bladder. The cather is inserted through the urethra. GentleCath Glide intermittent catheter is intended for adult use only.

A hydrophilic urological catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids from the bladder. The tip/distal end of the tube are inserted into the urethra and the funnel/connector end is used to drain the urine or can be connected to a urine drainage bag. The device is made using Polyolefin Based Synthetic Thermoplastic Elastomer (TPE) as base material with the addition of an additive material is hydrophilic and makes the surface slippery when wetted with water.

AQUACEL® Ag Surgical SP may be used for the management of wounds healing by primary intent (e.g., traumatic and elective post operative wounds/incisions) and as an effective barrier to bacterial penetration to help reduce infection. Under the supervision of a healthcare professional, AQUACEL™ Ag Surgical SP cover dressing may be used for the management of: Wounds healing by primary intent (e.g. traumatic and elective post operative wounds/incisions) and as an effective barrier to bacterial penetration to help reduce infection.

AQUACEL™ Ag Surgical SP dressing is a sterile post-operative dressing comprising of an inner (wound contact) non-woven pad composed of Hydrofiber™ technology and ionic silver which is stitch bonded with nylon and elastane yarns. The pad is held in place between a top layer of hydrocolloid adhesive which is bound to an outer polyurethane film and a windowed skin contact layer consisting of polyurethane film sandwiched between one layer of acrylic and one layer of Hydrocolloid contacting the skin. The outer layer of polyurethane film of AQUACEL™ Ag Surgical SP dressing provides a bacterial and viral barrier to reduce the risk of infection provided the dressing remains intact and there is no leakage. The highly absorbent central Hydrofiber™ pad absorbs and retains serosanguinous leakage and transforms into a soft gel which maintains a moist environment to support the body's healing process. The hydrocolloid component of the dressing provides secure, skin friendly adhesion and supports non traumatic removal of the dressing while minimizing damage to the intact surrounding skin. AQUACEL™ Ag Surgical SP dressing is a waterproof, bacterial and viral barrier dressing which is designed to conform to changes in the wound/incision geometry during body movement and post-operative edema. The dressing is intended for single use and is provided sterile (via a gamma irradiation process). This Special 510(k) details the modifications of the predicate device, AQUACEL™ Ag Surgical dressing, which form the AQUACEL™ Ag Surgical SP dressing. These modifications do not alter the intended use or indications for use.