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Epicel (cultured epidermal autografts) is an aseptically processed wound dressing composed of the patient’s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts. Epicel consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft. Each graft of Epicel is attached to petrolatum gauze backing with titanium surgical clips and measures approximately 50 cm2 in area. Epicel is authorized by Federal law for use in adult and pediatric patients who have deep dermal or full-thickness burns comprising a total body surface area greater than or equal to 30%. Epicel may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.

Additional ultrafiltration unit for AquaA water purification system. AquaUF 4000 for: AquaA 3000 & AquaUF 4000 AquaA 3000 & AquaA2 3000 & AquaUF 4000 AquaA 4000 & AquaUF 4000 AquaA 4000 & AquaA2 4000 & AquaUF 4000 AquaA 2700H & AquaUF 4000 AquaA 2700H & AquaA2 2700H & AquaUF 4000 AquaA 2700H & AquaA2 2700H & AquaHT & AquaUF 4000 AquaA 3600H & AquaUF 4000 AquaA 3600H & AquaA2 3600H & AquaUF 4000 AquaA 3600H & AquaA2 3600H & AquaHT & AquaUF 4000 The AquaA water purification system is a modular reverse osmosis unit intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. This device is intended to be a component in a complete water purification system and is not a complete water treatment system. The reverse osmosis unit must be preceded by pre-treatment devices and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.

Additional ultrafiltration unit for AquaA water purification system. AquaUF 2250 for: AquaA 1000 & AquaUF 2250 AquaA 2000 & AquaA2 1000 & AquaUF 2250 AquaA 2000 & AquaUF 2250 AquaA 2000 & AquaA2 2000 & AquaUF 2250 AquaA 900H & AquaUF 2250 AquaA 1800H & AquaA2 900H & AquaUF 2250 AquaA 1800H & AquaA2 900H & AquaHT & AquaUF 2250 AquaA 1800H & AquaUF 2250 AquaA 1800H & AquaA2 1800H & AquaUF 2250 AquaA 1800H & AquaA2 1800H & AquaHT & AquaUF 2250 The AquaA water purification system is a modular reverse osmosis unit intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. This device is intended to be a component in a complete water purification system and is not a complete water treatment system. The reverse osmosis unit must be preceded by pre-treatment devices and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.

DEVICE DESCRIPTION The GreenEgg™ is a sterile, single-use hand held, non-powered pelvic manipulator used for surgical manipulation and transillumination of the rectum and/or vagina. The 30mm diameter polymer tip fluoresces when viewed under a near infrared system PACKAGING CONTENTS A single GreenEgg™ device is CSR wrapped and placed inside a Tyvek header bag in sterile fashion. INDICATIONS FOR USE The EndoGlow GreenEgg™ manipulator is indicated to provide manipulation of the vaginal or rectum during minimally invasive surgical procedures. When viewed with the NIR camera system of a laparoscope or surgical robot, the GreenEgg™ will fluoresce providing transillumination DIRECTIONS FOR USE Confirm exp date. Remove bag from box, open the bag using sterile technique. Transfer the contents of the bag (CSR blue wrapped GreenEgg™ manipulator) to sterile field Once introduced to the field, the CSR wrap can be removed from the device and discarded. The GreenEgg™manipulator is ready for use Insert the GreenEgg™ manipulator into the vagina or rectum and proceed with surgical procedure CONTRAINDICATIONS The GreenEgg™ is a nonpowered, handheld manipulator, do not use it outside of standard surgical protocol or techniques WARNINGS Contents supplied sterile. Do not use if sterile barrier is damaged Do not use the GreenEgg™ if the device has been opened or damaged CAUTION U.S. Federal law restricts this device to sale by or on the order of a physician STORAGE Store at room temp, avoid extreme temps DISPOSAL Dispose of in accordance with all applicable Federal, State, and local Medical/ Hazardous waste practices REUSE PRECAUTION STATEMENT For single use only: Do not reuse, re-process or re-sterilize. Do not reuse, reprocess, or re-sterilize. Attempting to re-sterilize and reuse the product may diminish its intended performance in transilluminating tissue, reducing its effectiveness. To ensure optimal results and patient safety, a new product must be used for each procedure.

The Kegelfit is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress incontinence in women. The Kegelfit is a powered muscle stimulator used for strengthening the pelvic floor muscles. It sends a gentle stimulation (similar to your natural nerve impulses) direct to your pelvic floor muscles through a vaginal Trainer with stainless steel electrodes. These signals make your pelvic floor muscle contract. If you have forgotten how to contract your pelvic floor, are having trouble getting muscle response, or simply want to bring back the condition of your pelvic floor muscles, the Kegelfit can work them for you to build up their strength and help you to develop your own muscle control. It perfectly complements pelvic floor exercises. The kegelfit is very easy to use, with two preset training programs, two choices of exercise time and simple push button control. Stimulator, Electrical, Non-implantable, for Incontinence – Title 21, Code of Federal Regulations Sec.876.5320 ProCode: KPI Regulation Number: 21 CFR 876.5320 Regulatory Class: II

The Kegelfit is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress incontinence in women. The Kegelfit is a powered muscle stimulator used for strengthening the pelvic floor muscles. It sends a gentle stimulation (similar to your natural nerve impulses) direct to your pelvic floor muscles through a vaginal Trainer with stainless steel electrodes. These signals make your pelvic floor muscle contract. If you have forgotten how to contract your pelvic floor, are having trouble getting muscle response, or simply want to bring back the condition of your pelvic floor muscles, the Kegelfit can work them for you to build up their strength and help you to develop your own muscle control. It perfectly complements pelvic floor exercises. The kegelfit is very easy to use, with two preset training programs, two choices of exercise time and simple push button control. Stimulator, Electrical, Non-implantable, for Incontinence – Title 21, Code of Federal Regulations Sec.876.5320 ProCode: KPI Regulation Number: 21 CFR 876.5320 Regulatory Class: II

The Reference Plasma Quality Control Kit is for use with the Sonoclot® Analyzer System to verify performance of activated cuvettes. Testing should be performed prior to the use of a new shipment of activated cuvettes and monthly throughout use of the stock. More frequent testing may be required to comply with local, state and federal QC requirements. Reference plasma quality control is important to properly verify proper performance of coagulation test activators. A two level testing approach is used to perform quality control of the activator used in an activated coagulation test. Level I is run with the activator on the reference plasma. Level II is run with the non-activated test on the reference plasma. These two tests confirm the effectiveness of the activator to perform its intended coagulation activation. Each Kit contains: 1 vial Reference Plasma Control - 6 ml vial containing a lyophilized preparation of citrated animal plasma, stabilizers and buffer. Contains no human material. 1 vial Distilled Water - 6 ml vial containing 5.0 ml laboratory grade distilled water. 1 vial 0.02 M Calcium Chloride - 6 ml vial containing 5.0 ml 0.02 M Calcium Chloride. 5 plastic 1 ml syringes 2 non-activated test cuvettes (blue with clear caps, stir bars, and probes)

AIR SUPPLY Air supply units may be compatible with PremierPro™ Air Transfer Mats if they provide 3 psi pressure and 80 cfm capacity. The hose used may be a standard 1.75" diameter hose that may be secured with a snap fastener or hook & loop fastener. Always refer the air supply unit's operating instructions, observing all precautions and warnings. All safety guidelines within the air supply unit's operating instructions should be followed. MRI SAFETY PremierPro™ Air Transfer Mats may be used in situations that require transferring patients undergoing Magnetic Resonance Imaging (MRI). PremierPro™ Air Transfer Mats have been evaluated for use with MRI and have been determined to be safe for use. This conclusion is based on the following factors: Materials of construction for top and bottom fabrics include Nylon, PVC and Mesh. Safety strap buckles are constructed from Polypropylene. Air supply fasteners are manufactured from non-ferrous metal. Air supply fasteners are not in the radio frequency field or the field of imaging and will not cause artifacts. Evaluation of these factors indicates PremierPro™ Air Transfer Mats are safe when used with patients undergoing MRI. CLEANING Disposable Models The PremierPro™ Disposable Air Transfer Mat is not intended to be laundered and reused. Check Local, State and Federal Guidelines before disposing of this product.

AIR SUPPLY Air supply units may be compatible with PremierPro™ Air Transfer Mats if they provide 3 psi pressure and 80 cfm capacity. The hose used may be a standard 1.75" diameter hose that may be secured with a snap fastener or hook & loop fastener. Always refer the air supply unit's operating instructions, observing all precautions and warnings. All safety guidelines within the air supply unit's operating instructions should be followed. MRI SAFETY PremierPro™ Air Transfer Mats may be used in situations that require transferring patients undergoing Magnetic Resonance Imaging (MRI). PremierPro™ Air Transfer Mats have been evaluated for use with MRI and have been determined to be safe for use. This conclusion is based on the following factors: Materials of construction for top and bottom fabrics include Nylon, PVC and Mesh. Safety strap buckles are constructed from Polypropylene. Air supply fasteners are manufactured from non-ferrous metal. Air supply fasteners are not in the radio frequency field or the field of imaging and will not cause artifacts. Evaluation of these factors indicates PremierPro™ Air Transfer Mats are safe when used with patients undergoing MRI. CLEANING Disposable Models The PremierPro™ Disposable Air Transfer Mat is not intended to be laundered and reused. Check Local, State and Federal Guidelines before disposing of this product.

OneTouch Reveal Plus is a private-labeled version of BlueStar. DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStar is not a pill or a shot — it's a completely new kind of approach to support you and help you manage your type 1 or type 2 diabetes. BlueStar’s real-time coaching fits into your daily life helping you stay on track with your diabetes self-care. It works with you, struggles with you, achieves with you, and celebrates with you. It can help make living with diabetes easier which makes for a healthier, happier you. BlueStar is accessible from your mobile phone, tablet, or computer, and supports your healthcare provider’s instructions while providing you with diabetes education and motivational support. COORDINATE YOUR CARE WITH YOUR DOCTOR Before your next diabetes check-up, you can use BlueStar to send your information to your doctor. This helps your healthcare provider understand the challenges that you face between appointments so that during your office visit you can discuss a treatment plan that is just right for you. INDICATION FOR USE BlueStar is indicated for use by healthcare providers and their adult patients, aged 18 years and older, who have type 1 or type 2 diabetes. BlueStar provides secure capture, storage, and transmission of diabetes data, as well as, motivational, behavioral, and educational coaching messages to aid in diabetes self-management. BlueStar is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. CONTRAINDICATIONS: Patients on insulin pumps, patients less than 18 years of age, and women who are pregnant. IMPORTANT SAFETY INFORMATION: For medical questions, please contact your healthcare provider. If you are experiencing an emergency, please dial 911. Caution: Federal law restricts this device to sale by or on the order of a physician. For more information visit www.bluestardiabetes.com