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The Monoject™ Enteral Syringe with ENFit Connector is indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids, either orally or enterally, into the gastrointestinal system of a patient. The orallenteral syringes are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age groups.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

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Cardinal Health™ SMARTGOWN™ Surgical Gown with ASSIST™ Instrument Pockets is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The gowns meet the barrier protection requirements of AAMI Level 4 per ANSI/ AAMI PB70 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities. The Cardinal Health™ SMARTGOWN™ Surgical Gown with ASSIST™ Instrument Pockets is a single use, disposable medical device provided sterile and non-sterile. Non-sterile gowns are to be sold to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135 prior to marketing to the end user

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Cardinal Health™ Level 1 Surgical Mask with Anti-fog Hydrogel are intended to be worn by operating room personnel and other general healthcare workers to protect both the patients and the healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates. The Cardinal Health™ Level 1 Surgical Mask with Anti-fog Hydrogel are single use, disposable devices provided non-sterile. Cardinal Health™ Level 3 Surgical Mask with Anti-fog Hydrogel are intended to be worn by operating room personnel and other general healthcare workers to protect both the patients and the healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates. The Cardinal Health™ Level 3 Surgical Mask with Anti-fog Hydrogel are single use, disposable devices provided non-sterile.

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Monoject Magellan Insulin Safety Syringes are intended for delivery of U-100 insulin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks.

The Monoject™ Magellan™ Insulin Safety Syringe consists of a piston syringe with a permanently attached needle, and safety shield designed to extend, fully cover, and permanently lock over the needle when activated by a fingertip or thumb to reduce the occurrence of accidental needle sticks. The device is provided sterile and is intended for single use only. An orange needle cap indicates for use with insulin. The barrel of the syringe is graduated for measuring a prescribed dose. The syringe is intended for use immediately after filling and is not intended to contain or store insulin for extended periods of time.

Intended Use The Kendall SCD SmartFlow Compression system (hereby referenced as "Kendall SCD SmartFlow") is designed to apply Intermittent Pneumatic Compression (IPC) to increase venous blood flow in atrisk patients in order to help vein thrombosis and pulmonary embolism. The system, additionally, will enhance circulation and treats venous stasis, addressing associated symptoms such as pain and swelling. The system consists of the tubing assemblies (provided with the controller) and single-patient use garments (purchased separately from this controller). The garments, both leg sleeves and foot cuffs, compress the limbs to enhance venous blood movement. After the compression cycle, the controller measures the time it takes for the limbs to refill with blood and adjusts the compression frequency to maximize flow rate. The system may be used for all ages of adults and children when indicated to apply intermittent pneumatic compression. System is also designed to increase venous blood flow in at-risk patients, including bariatric and morbidly obese patients, in order to help prevent deep vein thrombosis and pulmonary embolism. The system is intended for use in a clinical setting by health care professionals. Indications Leg Compression The use of the Kendall SCD SmartFlow Compression System with Sequential, Gradient, Circumferential (SGC) compression is indicated for: - · Deep Vein Thrombosis and Pulmonary Embolism Prophylaxis. - · Treatment of pain and swelling related to venous stasis - · Circulation enhancement The use of the Kendall SCD SmartFlow Compression System with uniform, posterior compression is indicated for: · Deep Vein Thrombosis Prophylaxis. Foot Compression The use of the Kendall SCD SmartFlow Compression System with foot compression is indicated for: - · Circulation Enhancement - · Deep Vein Thrombosis Prophylaxis - · Edema Acute - · Edema Chronic - · Extremity Pain Incident to Trauma or Surgery - · Leg Ulcers - · Venous Stasis

The Kendall SCD SmartFlow Compression system (hereby referenced as "Kendall SCD SmartFlow") is designed to apply Intermittent Pneumatic Compression (IPC) to increase venous blood flow in atrisk patients in order to help vein thrombosis and pulmonary embolism. The system, additionally, will enhance circulation and treats venous stasis, addressing associated symptoms such as pain and swelling. The system consists of the tubing assemblies (provided with the controller) and single-patient use garments (purchased separately from this controller). The garments, both leg sleeves and foot cuffs, compress the limbs to enhance venous blood movement. After the compression cycle, the controller measures the time it takes for the limbs to refill with blood and adjusts the compression frequency to maximize flow rate. The system may be used for all ages of adults and children when indicated to apply intermittent pneumatic compression. System is also designed to increase venous blood flow in at-risk patients, including bariatric and morbidly obese patients, in order to help prevent deep vein thrombosis and pulmonary embolism. The system is intended for use in a clinical setting by health care professionals.

Intended for delivery of enteral fluids, including nutritional fluids and/or water to the gastrointestinal system via nasogastric, orogastric, nasojejunal, gastrostomy, and jejunostomy tubes. Not for use with neonates. Intended for any patients ages infant, child/adolescent and adult who are physically unable to eat and swallow or who are unable to get sufficient nutrition through eating and swallowing. Intended to be used in hospital and acute care settings, as well as long term and home care settings by users ranging from clinicians to laypersons and patients. Some patients may need a caregiver to support using the device. It is intended to be used in both stationary and ambulatory conditions including ground and air transport while using backpack accessory. The Kangaroo OMNI™ Enteral Feeding Pump and Feeding Set are intended to be used together as a system. Kangaroo OMNI™ Enteral Feeding Sets for administration of standard formula are able to be connected to access devices of all sizes that are ENFit™ compatible. The Kangaroo OMNI™ Thick Formula Feeding Sets for administration of thick formula can be used with access devices 8 Fr size or greater that are ENFit™ compatible.

The Kangaroo OMNI™ Enteral Feeding Pump, Kangaroo OMNI™ Feeding Sets and Kangaroo™ Accessories consist of an enteral feeding pump and disposable enteral feeding sets along with accessories that deliver fluids via rotary peristaltic tension loop pumping to provide hydration and nutrition for those who do not have the ability to orally ingest food or drinks.

The Salem Sump™ Silicone Dual Lumen Stomach Tube with ENFit™ Connection is intended for gastric decompression and administration of nutrition, fluids, and medication. The device is intended for patients with age of two and older.

The proposed Salem Sump™ Silicone Dual Lumen Stomach Tube with ENFit™ Connection is a dual lumen gastrointestinal enteral access tube made of medical grade silicone. The dual lumen design allows for decompression and administration of fluids within the larger (main) lumen while simultaneously allowing air to enter the secondary (vent) lumen during suctioning. This prevents invagination of the stomach wall into the tube eyelets during gastric decompression. During the period that decompression is needed, delivery of nutritional fluids such as formula, hydration or medication may be delivered through the main catheter lumen. The Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection contains an ISO 80369-3 compliant connector tethered to the Y-Shaft of the device. When nutritional fluid delivery is required, the male ENFit connector is inserted into the main lumen. The ENFit connector contains a female cap which helps the connector act as a lumen capping system when feeding or decompression is no longer required. Capping the lumen ends with the ENFit connector and the vent lumen cap helps aid in the prevention of gastric content leakage.

Cardinal Health™ RoyalSilk™ Surgical Gown is a single use, disposable medical device intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. This surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70).

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Cardinal Health™ Protexis™ PI Blue with Neu-Thera™ Surgical Gloves are powder-free surgeon's gloves that are disposable devices made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves have been tested for resistance to permeation of various chemotherapy drugs per ASTM D6978, "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs."

powder-free surgeon's gloves that are disposable devices made of synthetic rubber