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510(k) Data Aggregation
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(224 days)
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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(66 days)
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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(36 days)
The FX CorAL hemodialyzers are intended for single use only for extracorporeal blood purification during intermittent renal replacement therapies hemodialysis (HD), hemodiafiltration (HDF) using pre-, post or mixed-dilution modes, and isolated ultrafiltration for patients suffering from renal insufficiency, including pediatric patients.
Consider body and dialyzer surface area, blood flow, body weight and extracorporeal blood volume when selecting dialyzers for use with pediatric patients.
The FX CorAL dialyzers are high-flux, single-use, steam-sterilized hemodialyzers. The dialyzers are provided blood pathway sterile and non-pyrogenic. The dialyzers allow for the transfer of water and solutes between blood and dialysate using semipermeable, hollow fiber membranes.
The FX CorAL dialyzers are high-flux, sterile devices designed for single-use acute and chronic hemodialysis. The dialyzers are configured to connect to a bloodline set which connects to a patient's vascular access system when used with a hemodialysis machine equipped with ultrafiltration control. During hemodialysis, blood is pumped from the patient's body through an extracorporeal circuit, one component of which is the dialyzer. The dialyzers contain semipermeable membranes that allow for diffusion and/or ultrafiltration to transport toxins and excess fluid from the blood compartment (fiber lumen) to the dialysate compartment. Dialyzers utilize a counter-current flow in which dialysate and blood flow in opposite directions in the dialyzer during hemodialysis. The counter-current flow maintains the concentration gradient across the membrane for waste and fluid removal.
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(264 days)
The ADVIA Centaur Cytokeratin Fragment 21-1 (CYFRA) assay is for in vitro diagnostic use in the quantitative measurement of cytokeratin 19 fragments in human serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur XPT system.
The measurement of cytokeratin 19 is used as an aid in monitoring disease progression during the course of disease and treatment in lung cancer patients. Serial testing for patient CYFRA 21-1 assay values should be used in conjunction with other clinical information used for monitoring lung cancer.
The ADVIA Centaur Cytokeratin Fragment 21-1 assay includes 1 ReadyPack primary reagent pack containing ADVIA Centaur CYFRA Lite Reagent and Solid Phase and ADVIA Centaur CYFRA master curve card.
The ReadyPack consists of the following:
ADVIA Centaur Cytokeratin Fragment 21-1 ReadyPack primary reagent pack; Liquid Lite Reagent 10.0 mL/reagent pack KS19.1 monoclonal antibody acridinium conjugate in buffer containing bovine serum albumin; surfactant; and preservatives.
ADVIA Centaur Cytokeratin Fragment 21-1 ReadyPack primary reagent pack; Liquid Solid Phase Reagent 17.5 mL/reagent pack BM19.21 monoclonal antibody coupled to magnetic microparticle bead in buffer containing bovine serum albumin; surfactant; and preservatives.
ADVIA Centaur Multi-Diluent13 ReadyPack ancillary reagent pack; 2×10.0mL/reagent pack; Buffer; surfactant; sodium azide (< 0.1%)
This assay is a fully automated 1-step sandwich immunoassay using acridinium ester chemiluminescent technology. The Solid Phase contains magnetic microparticles coated with anti-CYFRA 21-1 BM19.21 mouse monoclonal antibody. The Lite Reagent consists of acridinium ester-labeled anti-CYFRA 21-1 KS19.1 mouse monoclonal antibody. A direct relationship exists between the amount of CYFRA 21-1 present in the patient sample and the amount of relative light units (RLUs) detected by the system.
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