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The Medline UNITE® REFLEX® Hybrid Nitinol Implants are intended to provide fixation for fractures, fusions or osteotomies of the bones of short (tarsals) and long (metatarsals, phalanges, distal tibia and fibula) bones comprising the foot and ankle such as: First metatarsal-cuneiform arthrodesis, First metatarsophalangeal arthrodesis, Talo-Navicular Fusion, Lis-Franc arthrodesis, Scarf and Chevron osteotomies. Implants are intended for single use only. The Medline UNITE® Locking and Non-Locking Cortical Screws are indicated for use with the Medline UNITE® REFLEX® Hybrid Nitinol Implant. The Non-Locking Cortical Screws are also indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

The Medline UNITE® REFLEX® Hybrid Nitinol Implants are manufactured from nickel titanium alloy (nitinol). The implants utilize chemical etching and passivation to form a protective oxidation layer on the outer surface. Chemical etching and passivation are common processes to create a uniform oxidation layer on the surface of the implant. The system includes implants offered in various styles, sizes, and options; each designed for specific anatomy and procedures. The implants can accommodate Ø2.7mm, Ø3.5mm, and Ø4.0mm locking and non-locking cortical screws to be used with the polyaxial locking holes and compression slots. The system also includes reusable and disposable instrumentation necessary for implantation of the REFLEX® Hybrid Nitinol Implant.

The Medline Level 4 Surgical Gown with Breathable Sleeves is a sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The Medline Level 4 Surgical Gown with Breathable Sleeves meets the Level 4 requirements of ANSI/AAMIPB70:2022 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. The Medline Level 4 Surgical Gown with Breathable Sleeves is also sold in a non-sterile version to repackagers/kitting entities, to be sterilized using the validated ethylene oxide sterilization method according to ISO 11135-1 in its final finished form, as a kit component.

The Medline Level 4 Surgical Gown with Breathable Sleeves is a single-use, sterile, disposable medical device that is provided in a variety of sizes (Large, X-Large, 3X-Large, 3X-Large and X-Long (only Sirus)) and styles (Sirus, Aurora and Eclipse). The Medline Level 4 Surgical Gown with Breathable Sleeves is constructed from nonwoven SMS (spunbond, meltblown, spunbond), a poly-fabric reinforcement on the chest front panel, and a breathable film (Polyester ether and polyester) for the sleeves. Each gown is designed with a hook and loop closure at the neck, ties at the waist, knitted cuffs at the end of the sleeves as well as a transfer tab for ease in donning. The Medline Level 4 Surgical Gown with Breathable Sleeves has been tested according to ANSI/AAMI PB70:2022 and meets AAMI Level 4 barrier level protection for a surgical gown.

The Hudson RCI Comfort Flo® CubCannula™ is a single use nasal cannula intended to administer respiratory gas to a spontaneously breathing patient through both nostrils delivering flow rates ranging from 1 to 25 LPM. CubCannula™ is a patient interface used to deliver heated and humidified gas to the following populations: - · Neonates, birth to 1 month of age - · Infants, 1 month to 2 years of age - · Children, 2 to 12 years of age CubCannula™ is designed for use in professional healthcare environments and must be prescribed by a physician. CubCannula is used in conjunction with the Humidification System intended to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients.

The Comfort Flo® CubCannula™ is a single patient use nasal cannula containing two-prongs intended to administer gas to a spontaneously breathing patient through both nostrils. CubCannula™ is a patient interface used as a conduit to deliver heated and humidified gas to the following pediations: neonates, infants, children. The nasal cannula incorporates soft prongs, a soft, silicone, kink and crush resistant lariat, in addition to a color-coded bolo for easy size identification. The CubCannulas will be available in five sizes: Extra Small (XS), Small (XS), Small (XS), Small (XS), Medium (M), Large (L), and Extra Large (XL). The nasal cannula will be secured to the patient's face via use of Hydrocolloid pads (CubPads™) to assist with easy positioning and change out of the cannula during use. The CubCannula™ will be individually packaged with a pair (2) of CubPad™ replacements will be available in a separate package.

The Medline Microdissection Needle is a monopolar electrosurgical instrument used for precision soft tissue dissection. It is a single-use device intended for cutting, dissecting, and cauterizing soft tissue. The Medline Microdissection Needle is not intended for use in the central nervous system or in the central circulatory system.

The Medline Microdissection Needle is a sterile, active electrode that is also referred to as a needle. It is designed for precision cutting, dissecting, and cauterization. The device is comprised of stainless steel, tungsten, and polyolefin heat shrink and will be offered in two different lengths, 4 cm (140936/ESE104A) and 3 cm (140937/ESE103A). The Medline Microdissection Needle is intended for connection with multiple brands of standard cautery pencils, including 510(k)-cleared Medline Cautery Pencil (K190643).

The Medline ReNewal Reprocessed Biosense Webster CS Catheter is indicated for electrophysiological mapping of cardiac structures, i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.

The reprocessed catheters are diagnostic bi-directional 7F deflectable mapping electrophysiology EP catheters. The devices have the ability to map electrical activity within the Coronary Sinus (CS) through electrodes along the catheters' pre-shaped tip. The catheters have a braided bi-directional tip section that provides the user with two 180° opposed single plane curves (available curves are DF and FJ). The tip is deflected with a Rocker Lever, and the high torque shaft permits the tip's plane to rotate to ease accurate positioning of the catheter tip at the desired site. The Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID are equipped with an Electronically Erasable Programmable Read Only Memory (EEPROM) that is used to store unique catheter identification information.

Hudson RCI® Comfort Flo nasal cannulas are intended to be used in conjunction with the Comfort Flo Humidification System to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients. It is indicated for single use by adult and pediatic (2 years and above) patients in professional healthcare environments. Hudson RCI® Comfort Flo® Plus cannulas are intended to be used in conjunction with the Humidification System to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients. It is indicated for single use by adult and pediative (12 years and above) patients in professional healthcare environments.

Hudson RCI® Comfort Flo Nasal Cannulas: Comfort Flo nasal cannulas are intended to be used in conjunction with the Comfort Flo Humidification System to provide a continuous flow of heated humidified air to spontaneously breathing patients. Sizes available include adult and pediatric. Hudson RCI® Comfort Flo Plus Cannulas: Cannula tube is assembled with other components to create a product named Comfort Flo® Plus Cannula with/ without Chin Strap. The Comfort Flo Plus cannulas are intended to be used in conjunction with the Humidification system intended to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients. It allows for the safe and effective delivery of heated, humidified oxygen therapy to the patients. The Comfort Flo Plus Cannulas are available in small, medium and large configurations. The chin strap is also offered individually. Hudson RCI® Comfort Flo Plus Cannulas: Comfort Flo Soft Plus cannulas are the same as Comfort Flo Plus cannulas except for head strap. These have a soft/cushioned head strap for patient comfort. It is used as an alternative to oxygen face mask and allows the patient to continue to talk, eat and drink while receiving the therapy. Hudson RCI® Tracheostomy Adaptor: The Hudson RCI® Tracheostomy Adapters are intended to be used in conjunction with tracheostomies in order to provide a secure connection to spontaneously breathing tracheostomy patients for oxygen therapy. It allows for the safe and effective delivery of oxygen therapy to the patient's trachea. The Tracheostomy Adaptor consists of 15mm (female) connector with cap deflector which enables it to be attached to 15M conical connector of tracheostomy tube/ patient connector port and swivel connector (15F/22M) at another end in order to connect with breathing circuit/ humidification system. It is indicated for single use by adult and pediatric (12 years and above) patients in professional healthcare environments.

Medline Reusable Sterilization Wrappers are intended to be used to enclose another medical device or component that is to be sterilized by health care professionals. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The Medline Reusable Sterilization Wrap is a non-sterile, reusable device, with a wash/dry/autoclave life cycle as indicated on the Wrap. Medline Reusable Sterilization Wrappers are available in 3 different fabrics that are either single or double ply bonded sheets of cotton and polyester blends. Model Angelstat is reusable up to 50 times; Models Resistat and Ripstop are reusable up to 75 times . The Medline Reusable Sterilization Wrappers are available in Misty Green, Jade Green or Ceil Blue with configurations 12"x12" through 72"x72" and 60"x90". The Medline Reusable Sterilization Wrappers are intended to be laundered then sterilized prior to use, and examined prior to use for defects and debris. A prevacuum steam sterilization cycle at 270 F for 4 minutes has been validated for use on textile packs, with a minimum weight of 25 pounds and 30 minute dry time. Medline recommends following the below standards for pack configuration and assembly in sterilization facilities. · AAMI ANSI ST79 • AAMI ANSI ST65

The Medline Reusable Sterilization Wrappers are offered in bulk, non-sterile packaging. The Medline Reusable Sterilization Wrappers are available in 3 different fabrics that are either single or double ply bonded sheets of cotton and polyester blends. The Medline Reusable Sterilization Wrappers are available in Misty Green, Jade Green or Ceil Blue with configurations 12"x12" through 72"x72" and 60"x90". The Medline Reusable Sterilization Wrappers are intended to be sterilized and laundered per the instructions.

The Medline UNITE® MIS Foot Recon Screw System is indicated for the stabilization and fixation of bone reconstructions, osteotomies, joint fusions (arthrodeses), and fractures of short (tarsals) and long (metatarsals, phalanges, distal tibia and fibula) bones comprising the foot and ankle. Screws are intended for single use only.

The Medline UNITE® MIS Foot Recon Screw System includes screws manufactured from Titanium Alloy (Ti-6Al-4V ELI) per ASTM F136 or IOS 5832-3. The screws are offered in various diameters from 2.5mm up to 4.0mm and overall lengths ranging from 14mm up to 70mm. The screws are single use and provided non-sterile intended to be cleaned and steam sterilized prior to use. The system also includes non-sterile, single use instrumentation necessary to implant the screws, e.g. drill bits and countersinks. Validated cleaning and sterilization instructions are included in the instructions for use.

The Hudson RCI Dri-Tech Breathing Circuits are intended for pediatric and adult patients in professional healthcare environments as a conduit of breathing gas between a patient and a ventilator and to maintain the temperature of humidified inspired gas.

The Hudson RCI® Dri-Tech Breathing Circuits are intended for pediatric and adult patients in professional healthcare environments as a conduit for respiratory gas between a patient and includes heated wire(s) for use with the Hudson RCI Neptune Heated Humidifier (K131912). The heated wires are intended to aid in maintaining the set patient temperature and minimize condensation in the ventilator tubing. The Dri-Tech Breathing Circuits are designed to be used with various patient interfaces such as oral tracheal tubes, nasal tracheal tubes, endo-bronchial tubes, and masks (for noninvasive ventilation therapies such as CPAP, BiPAP, and Mask usage). As such, Dri-Tech Breathing Circuits are designed and will be manufactured to conform to the test requirements of ISO 5367:2014 "Anaesthetic and respiratory equipment -- Breathing sets and connectors". The adult dual limb configuration consists of 19mm ID inspiratory limbs with 22mm connectors that are compliant to ISO 5356-1.2015 Anaesthetic and respiratory equipment – Conical connectors – Part 1: Cones and sockets. The adult circuits have a length of 1.7m on the inspiratory limb, and are kitted with the accessories described below: - Tubing Adaptor: 22mm male to male adaptor for various connections as required. - . Elbow Adaptor: Adaptor for connecting to the circuit wye to the patient interface to allow the circuit to exit the patient perpendicularly for optimal placement. - . Tubing Hanger: Optional accessory for hanging the circuit to reduce pull on the patient interfaces and ventilator/humidifier connections. - . Humidifier Limb: Required tubing and adaptors for connecting the ventilator inhalation port to the heated humidifier. Optional Ventilator Accessory available for the Dri-Tech Dual Limb Breathing Circuit: - . Dri-Tech Ventilator Accessory: Optional tee accessory capable of providing the 10 LPM flow required for the expiratory star lumen tubing. This ventilator accessory is comprised of male and female medical grade air DISS connectors to connect between the air hose and ventilator, a standard Christmas tree adaptor for connecting the tubing to, and an on/off valve to start and stop the flow. The adult single limb configuration is identical to the inspiratory limb of the dual limb configuration, however, is packaged with a different set of adaptors to facilitate connections and use with non-invasive therapies as described below: - Humidifier Line: Optional tubing and adaptors for connecting the ventilator inhalation port to the heated humidifier. - Exhalation Port Adaptor: Optional adaptor including an exhalation port and connector for the pressure monitoring line. - Pressure Monitoring Line: Optional accessory tubing for use with units without an Airway Pressure Monitor. - Pressure Monitoring Assembly: Optional accessory containing a tee and tubing for pressure monitoring on units with an Airway Pressure Monitor. - 15mm Adaptor: Optional accessory required for connecting to certain patient interfaces. - Male Luer: Optional accessory for required for certain setups to connect the pressure monitoring line. - Tubing Hanger: Tubing hanger designed for single limb tubes and pressure monitoring lines to reduce pull on the patient interfaces and ventilator/humidifier connections. - Bacterial/Viral Electrostatic Filter: Optional accessory in specific kit codes for user convenience. The Hudson RCI® Dri-Tech Breathing Circuits are sold non-sterile.