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The LNCS Sensors and Cables are indicated for the continuous nonitoring of functional oxygen saturation I he LNCS Sellsons and Cables are multided for and continued by an SpO2 sensor) for use with adult, pediatric, infant, and of arterial nemogroum (op(0)) and pare (motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.

The LNCS Oximetry Sensors are fully compatible disposable and reusable sensors for use with Masimo SET compatible pulse oximeter monitors. They represent a design change to the Masimo LNOP Oximetry Sensors. The LNCS DC-I/DC-IP reusable sensors are essentially identical to Masimo LNOP-DC-I/DC-IP sensors except for the connector at the end of the cable which interfaces with the LNCS patient cable. The emitter and detector are mounted in opposing halves of the molded clothespin style sensor with contoured pads to maintain contact with the patient's fingers. The same emitter (with Red wavelength of 658 nm and Infrared wavelength of 905 nm) and detector are used in both the LNCS DC-I/DC-IP and LNOP-DC-I/DC-IP sensors. The patient contacting materials in the LNCS DC-I/DC-IP and LNOP-DC-IP sensors are the same. The LNCS DC-I/DC-IP sensors are supplied non-sterile. The LNCS TC-I and TF-I reusable sensors are essentially identical to Masimo LNOP-Ear and TF-I sensors except for the connector at the end of the cable which interfaces with the LNCS patient cable. The same emitter (with Red wavelength of 653/659 nm and Infrared wavelength of 880 nm respectively) and detector are used in both the LNCS TC-I and TF-I and LNOP- Ear and TF-I sensors. The patient contacting materials in the LNCS TC-I and TF-I and LNOP- Ear and TF-I sensors are the same. The LNCS TC-I and TF-I sensors are supplied non-sterile. The LNCS disposable sensors are similar in construction to the predicate devices except that the LNCS sensors are cable based while the LNOP sensors are flex circuit based. The emitter and detector are connected to the cable assembly. The sensors have an adhesive bandage to allow the sensor to be attached to the patient's finger or toe. The same emitter (with Red wavelength of 658 nm and Infrared wavelength of 905 nm) is used in Masimo's LNOP series of disposable sensors. Four sizes of disposable LNCS sensors are available for use with adult, pediatric, infant and neonatal patients. The four sensors are essentially identical except for the emitter and detector spacing and size and orientation of the bandage material. The patient contacting materials in the LNCS disposable sensors are the same that is used in Masimo's LNOP sensor line. The LNCS disposable sensors are supplied non-sterile for single patient use. The LNCS patient cables are similar in construction to the predicate device enabling the LNCS Oximetry Sensors to be connected to Masimo and Masimo compatible pulse oximeter monitors.

The NC Adapter Cable with Nellcor sensors are indicated for the continuous noninvasive monitoring of functional I its readiner of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediation informator of Liveral In hospitals, hospitals, hospital-type facilities, mobile, and home environments.

The NC Adapter Cable is fully compatible oximetry cable that allows the use of Nellcor Sensors with Masimo SET Radical pulse oximeter monitors. The cable represents a design change to the Masimo patient cables and the MS board. The NC Adapter Cable is similar in construction to the predicate device enabling the Nellcor Sensors to be connected to Masimo SET Radical pulse oximeters. The NC Adapter Cable is designed, and manufactured for full compatibility with Masimo SET Radical pulse oximeters using Nellcor Sensors. The NC Adapter Cable is constructed of similar materials and components of equivalent specifications as used in the predicate devices.

The Masimo SET® Intellivue Pulse Oximeter Module is intended for the continuous noninvasive monitoring of functional oxygen saturerial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, and neonatal patients in hospitals and hospital-type facilities. The IntelliVue Pulse Oximeter Module is indicated for the continuous nonitoring of functional organization of financed for I ne ment vice culse oximicle moduced by an Spo-sensor). The Intellivie Pulse Oximeter Module is indicated for are with adult, pediatric and neonatal patients during both motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.

The Masimo SET® IntelliVue Pulse Oximeter Module is a continuous noninvasive, arterial oxygen saturation and pulse rate montor. The Masimo SET Intellivue Module features Masimo SET algorithms in a Philips single-width Intellivae compatible module.

The Masimo SET® Rad-5v Pulse Oximeter is intended for non-continuous noninvasive monitoring of finctional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO3 sensor) for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, and mobile environments. The Rad-5v Handheld Pulse Oximeter is indicated for the non-continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, and neonatal patients during both motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, and mobile environments. The Masimo SET® Rad5v Pulse Oximeter is indicated for the non-continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

The Masimo SET® Rad-Sv Handheld Pulse Oxineter is noninvasive, arterial oxygen saturation and pulse rate monitor. The Rad-ITIC Mannin SEE - Not of Principely that continuously displays numeric values for SpO2 and pulse rate, as well as LED indicator bars for Pulse Amplitude Index (PAI) and Signal Quality (SQ).

The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is intended for continuous nomitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatic, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments. The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories are indicated for use with adult, pediatic, and neonatal patients during both no motion and motions, for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments. In addition the Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is indicated to provide the continuous nonitoring data obtained from the Masimo SET® Radical Pulse Oximeter with SatShare™ of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) 10 multiparameter devices for display on those devices. The Masimo LNOP® Series of Sensors are indicated for the following: - A single use oximetry sensor intended for adults and pediatrics greater than 30 kg - A single use oximetry sensor intended for pediatrics and small adults greater than 10 kg and less than 50 kg - A single use oximetry sensor intended for neonates with good skin integrity less than 10 kg - A single use oximetry sensor intended for neonates with poor skin integrity less than 1 kg - A reusable oximetry sensor intended for adults and pediatrics greater than 30 kg - A reusable oximetry sensor intended for pediatrics and small adults greater than 10 kg and less than 50 kg The Masino PC Series of Patient Cables are indicated for use with the Masimo LNOP® Series of Sensors and the Masimo SET® Radical Pulse Oximeter with SatShareTM.

The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is a device consisting of the Masimo SET technology, connecting cable, and oximetry sensors to noninvasively calculate the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It features an easy-to-read display that presents patient data and status information: a LCD (liquid crystal display) display that shows the SpO2, pulse rate values, and a plethysmographic waveform, the current high and low SpO2 and pulse rate limit setting, and messages as appropriate.

The additional Masimo series of sensors are intended for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments. Reusable oximetry transflectance sensor intended for adults and pediatrics greater than 30 kg in hospital-type facilities, mobile, and home environments. The following additional Masimo Sensor is indicated for the continuous noninvasive functional of arterial hemoglobin (SpO2) and pulse rate: Reusable oximetry transflectance sensor intended for adults and pediatrics greater than 30 kg in hospitals, hospital-type facilities, mobile, and home environments.

The Masino series of oximetry sensors measure the light absorption of blood from two light emitting diodes (LED's). Oxygen saturated blood absorbs light differently than unsaturated blood. The amount of light absorbed by the blood is used to calculate the ratio of oxygenated hemoglobin in arterial blood. This filing includes the addition of 2 reusable sensors and a disposable sensor.

The Masimo SET® RAD-5 Pulse Oximeter is intended for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpOz) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, and mobile environments. The Rad-5 Handheld Pulse Oximeter is indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (Sp() ) and pulse rate (measured by an SpO2 sensor). The Rad-5 Handheld Pulse Oximeter is indicated for use with adult, pediatric and neonatal patients during both motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, and mobile environments. The Masimo SET® Rad 5 Pulse Oximeter is indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET® Rad 5 Pulse Oximeter is indicated for use with adult, pediatric, and neonatal patients during both no motion and ition conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

The Masimo SET® Rad-5 Pulse Oximeter is a handheld pulse oximeter that measures functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It utilizes spectrophotometry and plethysmography principles. The device displays SpO2, pulse rate, alarm status, alarm silenced status, Perfusion Index Bar, Signal IQ Bar, Battery Status, APOD, and FastSat. It has adjustable alarm volume and averaging settings. It is powered by 4 AA batteries.

The AC-1 Adapter Cable with Masimo 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, pediatic, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

The AC-1 Adapter Cable is fully conpatible oximetry cable that allows the use of Masimo LNOP Sensors with Nellow and Nellcor compatible pulse oximeter monitors. The cable represents a design change to the Masino patient cables. The AC-1 Adapter Cable is similar in construction to the predicate device enabling the Masimo LNOP Sensors to be comected to Nelleor and Nellcor compatible pulse oximeter monitors.

The SPO2.COM oximetry sensors and cables are intended for the continuous nominvasive monitoring of functional oxygen saturation of arterial hermoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

The SPO2.COM Oximetry Sensors are fully compatible disposable replacement sensors for use with Nellon and Nelloor compatible pulse oximeter monitors. They represent a design change to the Masimo LNOP Oximetry Sensors. The SPO2.COM RSI reusable sensor is essentially identical to Masimo LNOP-DCI sensor except for the end of the cable which interfaces with the Neller. The emitter and detector are mounted in opposing halves of the molded clothespin style sensor with contoured pads to maintain contact with the patient's fingers. The same emitter (with Red wavelength of 658 nm and Infrared wavelength of 905 nm) and detector are used in both the SPO2.COM RSI and LNOP-DCI sensors. The patient contacting materials in the SPO2.COM RSI and LNOP-DCI sensors are the same. The SPO2.COM RSI sensors are supplied non-sterile. The SPO2.COM disposable sensors are similar in construction to the predicate devices. The emitter and detector are connected to the cable assembly. The sensors have an adhesive bandage to allow the sensor to be attached to the patient's finger or toe. The same emitter (with Red wavelength of 658 nm and Infrared wavelength of 905 nm) is used in Masimo's LNOP series of stime that that tour sizes of disposable SPO2.COM sensors are available for use with adult, pediatric, infant and neonatal cuspount our sensors are cssentially identical except for the emitter and detector spacing and size and orientation of the bandage material. The patient contacting materials in the SPO2.COM disposable schsors are the same that is used in Masimo's LNOP sensor line. The SPO2.COM disposable sensors are supplied non-sterile for single patient use. The SPO2.COM patient cables are similar in construction to the predicate device enabling the SPO2.COM Oximetry Sensors to be connected to Nellcor and Nellcor The or oz. Out oximeters. The SPO2. COM oximetry sensors are constructed of similar materials and components of equivalent specifications as used in the predicate devices.

The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is intended for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO-) and pulse rate (measured by an SpO- sensor) for adult, pediativ, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments. The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motions, for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments. In addition the Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is indicated to provide the continuous nonitoring data obtained from the Masimo SET® Radical Pulse Oximeter with SatShare™ of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) to multiparameter devices for display on those devices. The Masimo LNOP® Series of Sensors are indicated for the following: - A single use oximetry sensor intended for adults and pediatrics greater than 30 kg - A single use oximetry sensor intended for pediatrics and small adults greater than 10 kg and less than 50 kg - A single use oximetry sensor intended for neonates with good skin integrity less than 10 kg - A single use oximetry sensor intended for neonates with poor skin integrity less than 1 kg - A reusable oximetry sensor intended for adults and pediatrics greater than 30 kg A reusable oximetry sensor intended for pediatrics and small adults greater than 10 kg and less than 50 kg The Masimo PC Series of Patient Cables are indicated for use with the Masimo LNOP® Series of Sensors and the Masimo SET® Radical Pulse Oximeter with SatShare™.

The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is a device consisting of the Masimo SET technology, connecting cable, and oximetry sensors to noninvasively calculate the functional oxygen saturation of arterial hemoglobin (SpO-) and pulse rate. It features an easy-to-read display that presents patient data and status information: a LCD (liquid crystal display) display that shows the SpO2, pulse rate values, and a plethysmographic waveform, the current high and low SpO2 and pulse rate limit setting, and messages as appropriate.