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510(k) Data Aggregation
(252 days)
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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(213 days)
The Sleepnet Arie Full Face Vented Mask is intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at or above 4 cm H2O. The mask is to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single-patient multi-use in the home, hospital, or institutional environment.
The Sleepnet Arie Nasal Vented Mask is intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at or above 4 cm H2O. The mask is to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single-patient multi-use in the home, hospital, or institutional environment.
The Sleepnet Arie Full Face Vented and Nasal Mask are designed based on the human facial shape, and the operating characteristics during application. The Sleepnet mask utilizes a Liquid Silicone Rubber (LSR) cushion design. The device is composed of medical-grade injection molded thermoplastics & clear liquid silicone rubber. The device is used as the interface between a CPAP/BiPAP machine and the end user. The masks are held in place with adjustable headgear that straps the mask to the face.
The Arie Full Mask is accompanied by a vented frame/tubing assembly which includes the Arie Full Face Vented Mask Headgear connector, valve, swivel ball, tubing, swivel connector assembly (swivel connector and clear swivel), and the JustFit Full Face Headgear with clips.
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(252 days)
Sterile Water for Inhalation, USP is intended to provide a supply of sterile water to unfilled respiratory humidifier chambers. It is intended to be used in institutional and non-institutional care settings. The intended patient population is Adults, Pediatrics, Infants and Neonates.
Sterile Water for Inhalation, USP is a sterile, single-dose medical device provided in flexible polyolefin bags, designed for safe and easy handling. The flexible polyolefin bags are prefilled with sterile water and feature a single polypropylene twist-off port used to transfer the sterile water to humidifier chambers using tubular feed sets. The humidifier chamber is then filled with sterile water from the bags via gravity. The device has a hanger to suspend the product during use.
Sterile Water for Inhalation, USP is not for parenteral administration or irrigation. The product is For Inhalation Therapy Only. It is supplied sterile and intended for single use only. Discard any unused portion.
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(29 days)
The DeltaWave Nasal Pillow System channels airflow noninvasively to a patient from a noninvasive positive airway pressure device (PAP) such as CPAP, bi-level.
It is intended for adult patients weighing ≥66lbs (30 Kg), and for whom positive airway pressure has been prescribed. It is intended for single patient reuse in the home and hospital/institutional/sleep center environment.
The DeltaWave Nasal Pillow System is a non-invasive medical device that directs pressurized air from a Continuous Positive Airway Pressure (CPAP) or Bi-level medical device to the patient. The subject device is a type of medical device prescribed by a physician or authorized professional for patients who have been diagnosed with Sleep Apnea. The subject device is designed to prevent pressure drop from the CPAP machine to the patient's nasal passages. That is accomplished by maintaining the same, or greater flow space from the machine output to the patient's nostrils. To further ensure the least amount of pressure drop the nasal pillows are designed to gently dilate the patient's nostrils to avoid restrictions to incoming air entering the nostrils. This allows air to enter the patient's nostrils at a lower driving pressure.
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(105 days)
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(266 days)
The Saans System is intended to provide continuous positive airway pressure (CPAP) support to spontaneously breathing neonates and infants weighing up to 10 kg who require respiratory assistance, including those with conditions associated with prematurity such as Respiratory Distress Syndrome (RDS). The device is intended for use in hospital environments.
The Saans System is a medical device designed to deliver Continuous Positive Airway Pressure (CPAP) therapy. The Saans System consists of the Saans device and accessories that work together to deliver the required therapy to the patient. This submission covers the Saans Device. The Saans device takes ambient air and oxygen as input and provides the mixed gas as output. This gas mixture is supplied to the humidifier, the output of which is connected to the breathing circuit. The breathing circuit is connected to the patient interface and the Bubble CPAP Generator.
The key features and functionalities of the Saans System are:
Gas Source and Mixture: The system utilizes an oxygen source and ambient air to create the required gas mixture for therapy. This blending approach allows for oxygen delivery to the patient.
User Interface and Control: The system incorporates a user interface enabling users to adjust and monitor various therapy parameters. Users can set the desired flow rate and oxygen concentration (FiO2).
Pressure Regulation: A Bubble CPAP Generator is employed to achieve the desired pressure levels within the system. The generator provides a continuous positive pressure in the patient's airways.
Monitoring: The Saans System provides displays of parameters such as delivered flow, pressure, and FiO2. The pressure is measured at the end of the inspiratory limb, right before the patient interface.
Safety: The Saans System provides safety alarms like blockage, leakage and FiO2 alarms
Delivery Mechanism: Heated and humidified respiratory gas is delivered to the patient through an inspiratory breathing circuit (Inspiratory Limb) connected to a nasal interface (Patient Interface). An expiratory circuit (Expiratory Limb) completes the loop, connecting the nasal interface to the Bubble CPAP Generator for pressure regulation.
Humidification and Accessories: An external humidifier is used to provide humidified gas. The details for the breathing circuits, nasal interface, humidification chamber, and Bubble CPAP generator are all a part of the information provided to the user in the User Manual.
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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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(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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(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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(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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