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510(k) Data Aggregation
(124 days)
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(267 days)
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(189 days)
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(65 days)
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(182 days)
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(182 days)
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(180 days)
The BAG is indicated for patients requiring total or intermittent ventilatory support. Ventilation is possible with or without supplemental oxygen. The BAG is intended to be used in both pre-hospital and healthcare facility environments.
The sizes versions also include indications for the patient population:
Adult: The Adult model is intended for patients over 20 kg (44 lbs).
Pediatric: The Pediatric model is intended for patients 2.5 - 20 kg (5.5 - 44 lbs).
Newborn: The Newborn model is intended for patients 2.5 - 5 kg (5.5 -11 lbs).
The BAG PEEP Valve is indicated for patients in need of ventilatory support with positive end-expiratory pressure (PEEP). The BAG PEEP valves can be used for all patient sizes indicated for The BAG manual resuscitator. The BAG PEEP valve is intended to be used in both pre-hospital and healthcare facility environments.
The BAG Manometer is indicated for measuring the gas pressure provided to a patient requiring total or intermittent ventilatory support. The BAG Manometer can be used for all patient sizes indicated for The BAG manual resuscitator. The BAG Manometer is intended to be used in both pre-hospital and healthcare facility environments.
The BAG is a non-sterile self-inflating manual resuscitator. It is indicated for patients requiring ventilatory support. Ventilation is possible with or without supplemental oxygen. The BAG manual resuscitator is intended for short-term use (< 24 hours per patient) and may be used multiple times on a single patient when kept free from contamination. It is available in three sizes: adult (for patients > 20 kg (44 lbs.)), pediatric (for patients 2.5-20 kg (5.5-44 lbs.)), and newborn (for patients 2.5-5 kg (5.5-11 lbs.)).
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(178 days)
The Oxygen Concentrator provides supplemental low flow oxygen therapy for adult in the home, nursing homes, patient care facilities, etc. It is available by prescription only under the supervision of a physician, and it's not intended to support or sustain life.
The Oxygen Concentrator is a portable concentrator which could utilize a molecular sieve and pressure swing adsorption to produce oxygen. The device can 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 5L/min. The nasal cannula is not sold with the device, users need to purchase accessories by themselves that are legally marketed. The products have not undergone biocompatibility assessment of condensate precipitates according to ISO18562-4.
The maximum altitude the subject device can operate without degradation of concentration is 2000m.
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(260 days)
Fisher & Paykel Healthcare OptiPAP Junior is for single-patient use and is intended to deliver noninvasive positive airway pressure (PAP) therapy to spontaneously breathing patients who require respiratory support.
OptiPAP Junior is designed for use in hospital environments where the patient is continually monitored and must be prescribed by a physician. It is intended for use by trained medical professionals on a pediatric subpopulation that includes neonates and infants from birth up to two years of age.
The F&P OptiPAP Junior is intended to deliver heated and humidified Positive Airway Pressure (PAP) therapy to neonates and infants requiring respiratory support.
The F&P OptiPAP Junior is a prescription-only device provided in a non-sterile state and intended to be used in a hospital environment and must be prescribed by a physician. The F&P OptiPAP Junior is for single- patient-use up to 14 days. The F&P OptiPAP Junior will be offered in multiple size variants.
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(169 days)
Unimed Reusable SpO2 Sensors are indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) in adult patients weighing greater than 30 kg who are either well or poorly perfused. The device is intended for use under no-motion conditions in professional healthcare environments. These devices are for prescription use only.
The subject device is Unimed Reusable SpO2 Sensors intended for non-invasive measurement of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) in clinical settings. The sensor is designed for compatibility with CSI 8100EP1, and is supplied non-sterile.
The sensor consists of a connector, a cable, and a finger clip housing incorporating a light-emitting diode (LED) and photodetector (PD). The subject device operates on the same principle and share similar design features, materials, and performance characteristics as the predicate device.
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