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510(k) Data Aggregation
(252 days)
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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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(245 days)
These devices are intended for use in providing tracheal access for airway management.
These devices are also intended for use with percutaneous dilatational tracheotomy (PDT) procedures.
The subject devices are sterile, single use dual cannula tracheostomy tube that has 90° curve and biocompatible radiopaque outer cannula with a distal or proximal extension (XLT) designed for patients with challenging anatomy.
All tracheostomy tubes feature flexible disposable inner cannula with full circumference at proximal end and a flexible laser-etched flange with integrated standard 15mm connector. The cuffed devices are provided with low-pressure TaperGuard™ cuff, featuring a thin compliant wall that, when inflated, adapts and conforms to the irregular borders of the tracheal wall. The cuffed devices have an inflation system consisting of an inflation line, pilot balloon and self-sealing inflation valve, allowing for inflation and deflation of the cuff.
The subject devices are manufactured from medical grade polyvinyl chloride (PVC) with non-Di(2-ethylhexyl) phthalate (DEHP) plasticizer and are sterilized by ethylene oxide (EO) sterilization method.
The cuffed and cuffless configurations of subject devices with distal and proximal extensions are available in four (4) sizes from 5.0mm to 8.0mm.
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(271 days)
The Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM is indicated for use in the routine monitoring of temperature, as well as heart and respiratory sounds, in an anesthetized patient. The device is intended for insertion into the esophagus.
The subject device of this premarket 510(k) notification is referred to as the Mon‑a‑Therm™ Esophageal Stethoscope with Temperature Sensor 400TM.
The legacy Esophageal Stethoscope (K811862) was originally cleared on July 10, 1981, under the name "Hi-Lo Temp® Esophageal Stethoscope with a Thermistor Sensor." It has since been renamed to "Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM."
The Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM is currently the marketed device that is undergoing a material modification to eliminate DEHP and Phthalates.
The Mon‑a‑Therm™ Esophageal Stethoscope with Temperature Sensor 400TM monitors temperature and heart and breath sounds.
Features and benefits:
- Soft, thin cuff
- Male Luer fitting conveniently attaches to standard acoustical earpieces
- Long lead wire keeps connector away from the surgical field
- Compatible with most multifunction patient monitors
The Mon‑a‑Therm™ Esophageal Stethoscope with Temperature Sensor 400TM is packaged individually as a sterile, single-use device and is available in the following sizes: 12 Fr 50/case CFN 90041, 18 Fr 50/case CFN 90042, 24 Fr 50/case CFN 90043, and 9 Fr 50/case CFN 90049. The device and its packaging are not made with natural rubber latex or phthalates. The type of probe and device size are designated on the unit package.
A 400 series thermistor is placed in a PVC clear tube and sealed by a blue plastisol cuff. This end of the tube is inserted into the esophagus and directly contacts mucosa. In the opposite end of the tube, there is a luer connector and a thermistor connector. The luer connector should be attached to a standard earpiece and the thermistor connector should be inserted to an appropriate interface cable.
Each probe is electrically connected to a compatible interface cable which is specified in Table 1. The interface cable connects the probe to a patient monitor, which is compatible with the 400 series thermistor, so that the temperature measurement value is displayed on the screen of the monitor. All patient monitors that meet the specifications for the 400 series thermistor, temperature accuracy, and compatible interface cables are compatible. Refer to Figure 3: Illustration of Patient Monitor Compatibility.
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(125 days)
The Portable Oxygen Concentrator(JLO-19P) provides a high concentration of oxygen to patients requiring supplemental oxygen. It may be used in home, institution, and transport modalities. This device is to be used as an oxygen supplement and is not intended to be life sustaining or life supporting.
The Portable Oxygen Concentrator JLO-190P is a device that uses the principle of molecular sieve pressure swing adsorption to increase oxygen concentration by adsorption of nitrogen and other gas components. The device needs to be used with a nasal oxygen cannula, which can provide oxygen supplementation to the user.
This product adopts the induction pulse mode to deliver oxygen. The induction pulse mode relies on the sensitive probe inside the machine to detect your breathing and deliver oxygen according to your breathing frequency. It monitors your breathing rate and delivers oxygen when you breathe in and stops when you breathe out.
Portable oxygen concentrator consists of air compressor, molecular sieve adsorption tower, oxygen storage tank, control system, alarm system, accessories (nasal oxygen cannula, lithium battery pack).
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