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NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) is intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician's prescription.

The NaturaLyte Dry Bicarbonate Concentrate (08-4112-2) is composed of dry sodium bicarbonate. NaturaLyte Dry Bicarbonate Concentrate (08-4112-2) is available in a 7807 g presentation that yields 25.36 gallons (96 liters) of bicarbonate concentrate volume. The 7807 g NaturaLyte Dry Bicarbonate Concentrate (08-4112-2) is supplied in bag-style packaging.

The NaturaLyte Dry Bicarbonate Concentrate (08-4112-2) is a non-sterile, single use Class II medical device composed of United States Pharmacopeia (USP) grade sodium bicarbonate.

NaturaLyte Dry Bicarbonate Concentrate (08-4112-2) is composed of sodium bicarbonate powder and is used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician's prescription. NaturaLyte Dry Bicarbonate Concentrate (08-4112-2) is formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis.

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The Flexicare FL-10000U Respiratory Humidifier is intended to warm and add humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance via an endotracheal tube or face mask. For use by trained personnel only within a hospital/institutional environment. This device is intended to be used with the Flexicare Autofill Humidification Chamber and Flexicare Heated Wire Breathing Circuit.

FL-10000U is an electrically powered Respiratory Humidifier that actively conditions the inspired respiratory gases delivered to ventilated patients and those receiving respiratory support. It is used as part of a complete system including a Humidification Chamber and either a heated wire breathing system.

FL-10000U Respiratory Humidifier is used with patients who require mechanical ventilation or positive pressure breathing assistance via an endotracheal tube and/or face mask.

The heater plate warms the water in the Humidification Chamber installed on to the top of the device. Gases are warmed and gain humidity in the form of water vapor as they travel along the breathing circuit on the to the patient.

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This Electric Wheelchair is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

The product is intended only carry one person and used as a means of transportation for people with disabilities or incomplete walking ability (excluding obesity).

The electric wheelchair is classified as class A, which is suitable for use on flat walking paths indoors and near buildings.

The maximum occupant mass is 100kg.

The Electric Wheelchair is a battery powered four wheeled vehicle.

It consists one Lithium battery with an off-board battery charger, frame, controller, motors, seat, back support, control device (including the battery power indicator, ON/OFF button, horn button, speed indicator, speed control button, joystick, lighting switch, USB interface), arm supports, two rear wheels, two casters(front wheels), Foot support, anti-tip devices.

The wheelchair can easily fold and unfold for transportation or storage.

The controller handle (joystick) is equipped on the control pad that attaches to the right arm rest. While there is a bluetooth music play function equipped on the left arm rest. The bluetooth function does not connect to the controller, so it will not affect the normal operation of the wheelchair at all.

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High-speed air turbine handpiece is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.

High-speed Turbine Air Handpiece is an instrument for drilling, grinding, repairing utilized in dental clinics. It composed of a head, a handle and a connector.

The subject device is intended to be used for dental professional use only.

Lubricant should be used during routine maintenance (e.g. after each patient use and prior to sterilization). The user must buy and use specified lubricant type "PANA SPRAY Plus" manufactured by NAKANISHI INC (cleared in K163483).

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Dental air motor handpiece is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.

Dental air motor handpiece is an instrument for drilling, grinding, repairing teeth that is utilized in dental clinics. It composed of handpiece and a connector, including low speed air motor, straight handpiece and geared angle handpiece. The subject device consists of 11 model variations:TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41. The device description of Dental air motor handpiece is as follows:

The gear ratios of handpieces have various gear ratios (for different geared angle handpiece);

Handpiece and adaptors can bear steam

The gear ratios of handpieces have a various gear ratio (for different geared angle handpiece) (1:1 (constant), 20:1 (speed reduction) and 4:1 (speed reduction));

The handpieces have maximum Forward rotation speed 24000rpm and maximum Reverse rotation speed of 24000 rpm.

The air motors are capable of running up to a speed of 24000 rpm, but can vary at different pressure of air supply.

Coupling is the accessory for handpiece to connect with tubes of dental unit. It could be divided into two types. It included 2-hole (drive air and water holes) and 4-hole coupling (drive air, exhaust air, spray air and spray water holes). The use of the coupling of handpiece is due to the number of tubes of dental unit.

The subject device is intended to be used for dental professional use only.

In order to avoid the risk, user must buy and use specified lubricant type "PANA SPRAY Plus" manufactured by NAKANISHI INC (cleared in K163483).

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The KabiHelp® Bag is an empty container to be filled with components of parenteral nutrition and parenteral nutrition related medication to be administered to the patients using an intravascular administration set. Parenteral nutrition and parenteral nutrition related medication transfer in and out of the container is done using aseptic technique.

The KabiHelp® Bag is an empty plastic container to be filled with components of parenteral nutrition and parenteral nutrition related medication to be administered to patients using an intravascular administration set. It is designed to be used with KabiHelp Pro Compounding System and KabiHelp Transfer Sets and Accessories.

Filling of the bags takes place in an aseptic environment. The bags are available in monolayer or multilayer models in various volumes.

All KabiHelp bags are equipped with three port types: (1) a filling port suitable for the KabiHelp Transfer Sets, (2) an injection port for manual injection of additives, and (3) an administration port for infusion therapy.

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The prostheses from FH Industrie are designed for specific indications such as:

Simple humeral prosthesis

• Humeral head necrosis without injury to the glenoid cavity.
• Extensive humeral head cartilage damage without injury to the glenoid cavity
• Centred osteoarthritis with a glenoid cavity not allowing implantation of a glenoid implant.
• Rheumatoid polyarthritis with thin rotator cuff.
• Off-centred osteoarthritis with irreparable cuff, and with maintained active elevation of at least 120°.

Total anatomical prosthesis (cemented glenoid implant with pegs)

• Centred glenohumeral osteoarthritis with functional rotator cuff
• Rheumatoid polyarthritis with functional rotator cuff
• Post-traumatic sequela, functional rotator cuff with glenoid injury.

TOTAL ANATOMICAL PROSTHESIS (POROUS GLENOID IMPLANT)

• Centred glenohumeral osteoarthritis
• Rheumatoid polyarthritis
• Post-traumatic sequela with glenoid injury
• Revision for glenoid loosening
• Glenoid bone loss, where bone graft is needed

A functional rotator cuff is necessary to use this device

REVERSE PROSTHESIS (METAL-BACK OR POROUS GLENOID IMPLANT)

The ARROW and JARVIS Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device.

At least 2/3 of the metaphyseal component must be implanted in the proximal humeral bone to allow for adequate humeral component fixation. Metaphyseal stems and diaphyseal stems are intended for use without cement. The glenoid bases (metal-back or porous) are intended for cementless use with the addition of cortical and cancellous bone screws.

The JARVIS Metaphyseal Stem is modification to the metaphysis component of the Arrow Short Stem prosthesis (K202024). The Metaphyseal Stem is intended to be used with the diaphyseal component of the modular ARROW Short Stem device (K202024), including the JARVIS Diaphyseal Stem Standard (K253345). The subject modifications include optimized leading edges as well as the inclusion of suture holes for soft tissue reattachment. The JARVIS Metaphyseal Stem is offered in various sizes to accommodate patient anatomy. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3 with a pure titanium plasma spray coating per ASTM F1580.

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The Oxygen Concentrator provide supplemental oxygen to patients who require supplemental O2, by separating nitrogen from room air, by way of a molecular sieve, it can be used in the home or health care facility. It is not intended to sustain or support life.

The Oxygen Concentrator is a portable concentrator which could utilize a molecular sieve and pressure swing adsorption to produce the oxygen. The device could separate nitrogen by absorbing through the molecular sieve when the room air enters the device, and allows the enriched oxygen to be collected. The device could provide approximately 90~96% of oxygen to patients on a continuous flow basis at a rate of 1L/min to 10L/min. The nasal cannula is not sold with the device, users need to purchase the accessories by themselves that are legally marketed. The products have not undergone biocompatibility assessment of condensate precipitates according to ISO18562-4, and it is not recommended to use humidification bottles. The maximum altitude the subject device can operate without degradation of concentration is 2000m.

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This product is intended for delivery of respiratory gases to adult patients in hospitals.

This product is indicated for the delivery of nasal high flow (NHF) and low-flow oxygen by appropriately qualified healthcare professionals.

Qualitative carbon dioxide (CO2) sampling can be used at nasal cannula flow rates from 5 to 50 L/min in operating and procedure rooms.

This product can be used for pre-oxygenation, short-term supplemental oxygenation (up to 10 minutes) during intubation, and allows an anesthesia mask to be placed over the nasal interface to perform mask ventilation, by individuals who perform anesthesia care or airway management.

This product is not intended for apneic ventilation.

This product is not indicated for use during CPR.

The Optiflow™ Switch+ Filtered Nasal Interface with CO2 Sampling interface is intended to deliver respiratory gases to the patient.

The subject device includes a CO2 sampling tube that provides a sample of the patient's exhaled respiratory gases through the CO2 sampling accessory to a CO2 sampling line and CO2 analyzer.

The subject device has been designed to allow for mask ventilation without the need to remove the nasal interface from the patient during therapy. To support this function, a Flow Diverter (K234053) is required.

The product is indicated for the delivery of nasal high flow (NHF) and low flow oxygen by appropriately qualified healthcare professionals.

This is a prescription-only device provided in a non-sterile state. It has a flow range of 5 to 70 L/min. The device will be offered in three sizes, small (S), medium (M), and large (L).

It is intended to be used in combination with a compatible respiratory humidifier, Optiflow Oxygen Kit and the Optiflow Flow Diverter (K234053).

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