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The Reprocessed RD SET pulse oximeter sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, and infant patients during non-motions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.

In a clinical setting, a pulse oximeter sensor measures the oxygen saturation of arterial blood (SpO2). A pulse oximeter sensor is composed of a light emitting diode (LED) and a sensor that are placed on opposite sides of a patient's finger or foot. The LED contains a red light and an infrared light that are differentially absorbed by oxygenated and deoxygenated hemoglobin. Based on the relative absorption of the two wavelengths that is determined by the sensor, the POX determines the relative amount of oxygenated and deoxygenated hemoglobin, which is calculated as SpO2. In order to make the SpO2 calculation independent of skin color, finger size, etc., the pulse oximeter sensor uses only the time varying light absorption component generated by the patient's pulse. The sensor also uses the period of pulsation to measure patient pulse rate. The pulse oximeter can estimate the amount of oxygen in the blood without having to draw a blood sample. The primary components of an oxygen transducer, or Pulse Oximeter (POX) Sensor, are lightemitting diodes (red and infrared LED) and a photo sensor. These components (with their wiring system) are embedded within a taping system designed for wrapping the POX Sensor around a patient's finger, foot, or hand so that the LED and photo sensor are directly opposite to each other. As the lights are emitted and received across a vascular bed, the rates of absorption at the two wavelengths vary depending upon the ratios of oxygenated and deoxygenated hemoglobin within the blood. As part of the reprocessing manufacturing process, we collect used devices from hospitals, replace required components, clean the devices and test the functional performance of the devices to ensure they meet or exceed requlatory requirements and the expectations of our customers.

The sensor is indicated for single patient use for continuous noninvasive arterial oxygen saturation and pulse rate monitoring.

In a clinical setting, a pulse oximeter sensor measures the oxygen saturation of arterial blood (SpO2). A pulse oximeter sensor is composed of a light emitting diode (LED) and a sensor that are placed on opposite sides of a patient's finger or foot. The LED contains a red light and an infrared light that are differentially absorbed by oxygenated and deoxygenated hemoglobin. Based on the relative absorption of the two wavelengths that is determined by the sensor, the POX determines the relative amount of oxygenated and deoxygenated hemoglobin, which is calculated as SpO2. In order to make the SpO2 calculation independent of skin color, finger size, etc., the pulse oximeter sensor uses only the time varying light absorption component generated by the patient's pulse. The sensor also uses the period of pulsation to measure patient pulse rate. The pulse oximeter can estimate the amount of oxygen in the blood without having to draw a blood sample. The primary components of an oxygen transducer, or Pulse Oximeter (POX) Sensor, are light-emitting diodes (red and infrared LED) and a photo sensor. These components (with their wiring system) are embedded within a taping system designed for wrapping the POX Sensor around a patient's finger, foot, or hand so that the LED and photo sensor are directly opposite to each other. As the lights are emitted and received across a vascular bed, the rates of absorption at the two wavelengths vary depending upon the ratios of oxygenated and deoxygenated hemoglobin within the blood. The proposed devices of this submission do not differ from the predicate device. The only difference is that the proposed devices will be exposed to vaporized hydrogen peroxide for sterilization instead of ethylene oxide.

The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor Model MAXNAR is indicated for single patient use when continuous non-invasive arterial oxygen saturation and pulse rate monitoring is required for adult patients as indicated in the sensor directions for use. This device is for prescription use only.

The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, model MAXNAR is designed for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in conjunction with a Nellcor Pulse Oximeter. The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, model MAXNAR, is intended for prescription use with adult patients in hospitals, hospital-type facilities, and intra-hospital transport. The proposed device is not provided sterile

The Medline ReNewal Reprocessed Masimo LNCS Adult and Pediatric SpO2 Adhesive Sensors are indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult and pediatric patients during no motion conditions, and for patients who are well perfused in hospitals and hospital-type facilities.

Medline ReNewal Reprocessed Masimo LNCS Adult and Pediatric SpO2 Adhesive Sensors, models LNCS Adtx, LNCS Pdtx, LNCS Adtx-3, and LNCS Pdtx-3 are designed for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in conjunction with instruments containing Masimo SET oximetry or licensed to use LNCS sensors. The Medline ReNewal Reprocessed Masimo LNCS sensor models LNCS Adtx, LNCS Pdtx, LNCS Adtx-3, and LNCS Pdtx-3 are intended for prescription use with adult and pediatric patients in hospitals, hospital-type facilities, and intra-hospital transport. The proposed device is not provided sterile.

OxiMax Adult: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients > 30 kg. OxiMax Pediatric: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients 10 - 50 kg. OxiMax Infant: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients between 3 kg and 20 kg. OxiMax Neonate: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients foot if < 3 kg, or finger if > 40 kg.

The ReNy Medical Reprocessed OxiMax Sensors are accessory devices to an oximeter monitoring system. The oxisensor is designed as a transducer for the transmission of electrical signals from the oximeter to the patient and the return of patient modified signals back to the oximeter for analysis and display of patient information. The sensor contains three optical components; two light emitting diodes (LEDs) serve as light sources and one photodiode acting as a light detector LED and sensor are contained in a laminated envelope provided with an adhesive bandage for attachment a patient. A sensor package is attached to a cable terminated in a multi-pin connector that plugs into the oximeter.

The M-LNCS Sensors are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate (measured by an SpO₂ sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments. The Reprocessed M-LNCS Sensors are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.

The M-LNCS and Reprocessed M-LNCS Oximetry Sensors are fully compatible disposable sensors for use with instruments which include or compatible with the following technologies: - · Masimo SET technology - · Masimo Rainbow SET technology - · Nellcor technology The M-LNCS series has been validated with Masimo SET Oximetry Technology and on Nellcor's N-200 Pulse Oximeter. The saturation accuracy of the Neonate and Preterm sensors were validated on adult volunteers and 1% was added to account for properties of fetal hemoglobin.

The reprocessed pulse oximeter sensors are indicated for use for continuous noninvasive arterial oxygen saturation (SpO2) and pulse rate monitoring.

SterilMed's reprocessed pulse oximeter sensors consist of a sensor, integrated sensor cable, and a sensor plug which connects to the Pulse Oximeter. These devices feature a sensor that uses an optical means to determine the light absorption of functional arterial hemoglobin. The sensor contains three optical components: two light emitting diodes (LED's) that serve as light sources, and one photodiode, that acts as a light receiver. The oximeter sensor is positioned so that the LED's and photodiode oppose one another across the tissue. The sensor is connected via cable to a pulse oximeter, which provides continuous noninvasive, self-calibrated measurements of both oxygen saturation of functional hemoglobin and pulse rate.

The MRC Reprocessed Pulse Oximeter sensors are used as a noninvasive method to provide continuous SpO2 monitoring and pulse rate monitoring. These devices are intended for prescription use.

The Midwestern Reprocessing Center reprocessed pulse oximeter sensors are non-invasive sensors used to provide continuous SpO2 monitoring and pulse rate. The sensors contain a dual wavelength light emitting diode (LED), and an optical photodiode sensor which are housed in a pad which attaches to the patient using adhesive material. The LED emits red and infrared light in alternate pulses, governed by the Oximeter instrument. The photodiode sensor responds to the light and generates a current that is interpreted by the Oximeter instrument. The Oximeter instrument interprets the different amounts of each light type (red and infrared) from the output of the photodiode and interprets the information and displays a reading. The sensor operates without any type of tissue penetration, electrical contact, or heat transfer to the patient. The sensors use optical means to determine the light absorption of functional arterial hemoglobin. The sensor is indicated for use as a non-invasive method to provide continuous SpO2 monitoring and pulse rate.

The reprocessed pulse oximeter sensors are indicated for use for continuous noninvasive arterial oxygen saturation (SpO2) and pulse rate monitoring.

SterilMed's reprocessed Masimo LNCS® Pulse Oximeter Sensors consist of a sensor, integrated sensor cable, and the sensor plug which connects to the Pulse Oximeter. The reprocessed Masimo LNOP® Pulse Oximeter Sensors consist of a sensor (two LED's and a photodiode), connector extension and connector, but do not feature an integrated cable. Both configurations have a sensor that uses an optical means to determine the light absorption of functional arterial hemoglobin. The sensor contains three optical components: two light emitting diodes (LED's) that serve as light sources, and one photodiode, that acts as a light receiver. The oximeter sensor is positioned so that the LED's and photodiode oppose one another across the tissue. The sensor is connected via cable to a pulse oximeter, which provides continuous noninvasive, self-calibrated measurements of both oxygen saturation of functional hemoglobin and pulse rate. Note: Only the pulse oximeter sensor is the subject of this submission, the oximeter and any other related equipment are not included in the scope of this submission.