Search Results

SmartBag is intended for use inside and out of hospitals for any patient with a diversionary urinary or fecal stoma. It works in conjunction with 11 Health's care management platform known as Alfred. The SmartBag system uses integrated sensors to continuously monitor bag filling and drainage, providing cumulative output data to the patient and clinical team. The system also monitors skin condition, the occurrence of leaks and visual condition of the stoma. SmartBag's intended use is to help ostomates acclimate to their lifestyle. It works in conjunction with 11 Health's care management platform known as Alfred, designed for patients and medical professionals. The SmartBag system (including the wafer and Hub), offers a continuous ostomy monitoring system, tracks the estimated volumetric filling of the bag and visual condition of the stoma using integrated sensor technology. The SmartBag Sytem is for adult use only. (22 years and above)

The SmartBag with integrated thermistors and capacitive sensors can be used in place of a traditional ostomy bag. It notifies patients or medical professionals of any potential leaks around the peristomal skin as well as giving an estimate of the output volume within the bag. Alfred software is a companion software suite for SmartBag. It consists of Alfred mobile app and Alfred hospital app. Alfred mobile app is a companion application for mobile phone. The application provides SmartBag user easy access to bag status, hydration tracking and restroom search functionalities. The SmartBag could operate without Alfred mobile app. The sensors in the bag and the wafer will be able to transmit data to the hub via NFC protocol communication. The data from the hub will be transmitted to the cloud via LTE-M data transfer via secure MQTT protocol and then this data can be downloaded to web supported devices – such as an iPhone.

The OSTOM-i™ Alert is intended to be used as an accessory to any ostomy bag by monitoring the filling of the bag which information is sent via Bluetooth to a tablet computer to warn healthcare personnel when a patient's bag is close to being full. The Tablet computer automatically captures the data as to the volume and timing of output for each patient. The OSTOM-i™ Alert is indicated for all patient populations. The sensor-based OSTOM-i™ Alert attaches to any ostomy bag and is able to send messages via Bluetooth to a mobile app to warn patient when ostomy bag is close to being full. The sensor-based OSTOM-i™ Alert is intended to be used by the hospital environment. The OSTOM-i™ Alert is indicated for all patient populations.

The sensor-based OSTOM-i™ Alert attaches to any ostomy bag and is able to send messages via Bluetooth to a mobile app to warn the health care provider when their patients' bags are close to being full, or to the patient in the post-hospital setting. The flex sensor changes its resistance according to curvature and converts resistance into mls, thereby detecting the progressive filling of the bag. This information is relayed to the tablet generating an additional report on bag status versus the visual one now available.

The VITALA™ Continence Control Device is a single-use device intended to prevent the release of stool from an end colostomy while allowing any flatus from the stoma to be deodorized and released. To be used only with a 1 ¾ in. (45 mm) or 2 ¼ in. (57 mm) ConvaTec NATURA® skin barrier.

The Vitala™ Continence Control Device is a pouchless ostomy device consisting of a self-inflating Air Seal which contacts a stoma and is held against the stoma with a low pressure, allowing flatus to be deodorized and vented while retaining stool. The Air Seal contains a soft foam insert that expands to fill the Air Seal, causing the Air Seal to expand with it. As it expands, the Air Seal gently contacts the stoma and conforms to the shape of the stoma, and is held against the stoma with a low pressure. The Air Seal will re-inflate to remain in contact with the stoma retracts or moves away from the Air Seal. The Vitala™ Continence Control Device also includes an expandable container to collect stool during removal of the device. This single use device is designed to be used only with a 1 ¾" (45mm) or 2 ¼" (57mm) ConvaTec Natura® skin barrier, and will accommodate a range of stoma diameters. This 510(k) notification concerns a design modification for the Vitala™ Continence Control Device to allow its use with ConvaTec Moldable Technology™ skin barriers.

The VITALA™ Continence Control Device is a single-use device intended to prevent the release of stool from an end colostomy while allowing any flatus from the stoma to be deodorized and released. To be used only with a 1 ¾ in. (45 mm) or 2 ¼ in. (57 mm) ConvaTec NATURA® skin barrier. Not intended for use with ConvaTec Moldable Technology™ skin barriers.

The Vitala™ Continence Control Device is a pouchless ostomy device consisting of a self-inflating Air Seal which contacts a stoma and is held against the stoma with a low pressure, allowing flatus to be deodorized and vented while retaining stool. The Air Seal contains a soft foam insert that expands to fill the Air Seal, causing the Air Seal to expand with it. As it expands, the Air Seal gently contacts the stoma and conforms to the shape of the stoma, and is held against the stoma with a low pressure. The Air Seal will re-inflate to remain in contact with the stoma if the stoma retracts or moves away from the Air Seal. The Vitala™ Continence Control Device also includes an expandable container to collect stool during removal of the device. This single use device is designed to be used only with a 1 ½" (45mm) or 2 ¼" (57mm) ConvaTec Natura® skin barrier, and will accommodate a range of stoma diameters. The Vitala™ Continence Control Device is indicated for individuals with end colostomies. The device is not intended for use until the abdomen and peristomal area have fully healed from bowel surgery (typically 6-12 weeks post surgery), or for use with a stoma protrusion greater than 2 cm (when lying down). The device should also not be used in individuals with end colostomies with a history of chronic liquid stool. ConvaTec Moldable Technology™ skin barriers should not be used with the Vitala™ device. This 510(k) notification concerns modification of the labeling for the Vitala™ Continence Control Device to allow an expanded wear time of up to 12 hours per day for the device as well as expanded compatibility with ConvaTec Natura® convex products. Otherwise, the design, materials, and manufacture of the device remain unchanged from its description in 510(k) Premarket Notification K083785, except that its deflation shield is now made from polypropylene.

To prevent the release of stool from an end colostomy while allowing any gas that is present at the stoma to be deodorized and released. To be used only with a 1 ¼" (45 mm) or 2 1/2' (57 mm) ConvaTec Natura® skin barrier. Not intended for use with ConvaTec Moldable Technology™ skin barriers or convex products.

The Vitala™ Continence Control Device is a pouchless ostomy device consisting of a self-inflating Air Seal which contacts the stoma and is held against the stoma with a low pressure, allowing flatus to be deodorized and vented while retaining stool. The Air Seal contains a soft foam inserts that expands to fill the Air Seal, causing the Air Seal to expand with it. As it expands, the Air Seal gently contacts the stoma and conforms to the shape of the stoma, and is held against the stoma with a low pressure. This Air Seal will re-inflate to remain in contact with the stoma if the stoma retracts or moves away from the Air Seal. The Vitala™ Continence Control Device also includes an expandable container to collect stool during removal of the device. This single use device is designed to be used only with a 1 ¼" (45mm) or 2 ¼" (57mm) ConvaTec SUR-FIT Natura® skin barrier, and will accommodate a range of stoma diameters. The device is designed to be worn up to eight hours per day.

Smith & Nephew's "No Sting Skin Prep™" is intended for use as a liquid film - forming product that when applied to intact skin, forms a film for skin attachment sites for drainage tubes, external catheters, surrounding ostomy sites and adhesive dressings. a) "No Sting Skin Prep™" applies a coating that prepares the skin for adhesives and provides a protective interface that may reduce friction during the removal of tap:. "No Sting Skin Prep™" is indicated for skin attachment sites for draining tubes, external cather.ers, surrounding ostomy sites and other adhesive dressings. b) "No Sting Skin Prep™" can be used in sensitive stoma areas as a skin protectant and may reduce irritation from contact with body wastes and stoma fluid. c) "No Sting Skin Prep™" forms a protective film on skin that serves a: a skin protectant which may reduce exposure to urine and feces.

No-Sting Skin Prep™ is a water based alcohol free liquid impregnated on to a nonwoven wipe or tufted swab applicators. This product is sold OTC for use by ostomates and other individuals who wish to reduce trauma to skin upon removing adhesive devices/products. The product is applied to the skin and allowed to dry. The solvent base evaporates leaving a polymeric film on the skin. After drying, the adhesive device, dressing, Ostomy device, tape, etc., is attached.