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The Airway Gas Sampling Products are intended for continuous monitoring of expired and inspired respiratory gases. The Airway Gas Sampling Products are single patient use devices with a cumulative duration of use of up to 72 hours. The Airway Gas Sampling Products include Airway Gas Sampling Sets with integrated gas sampling lines, and an Airway Adapter without sample line, both for use with compatible GE Healthcare sidestream respiratory gas modules and patient monitors utilizing these modules. The Airway Gas Sampling Sets are provided in two sizes: large for use with adult/pediatric patients, and small for use with infant patients, for connection to the patient's breathing circuit. They are provided in two lengths: 3 meter/10 feet, and 2 meter/7 feet. The Airway Gas Sampling Sets are intended for continuous monitoring of Carbon Dioxide (CO2), Oxygen (O2), and respiratory rate in professional/hospital care environments where agents are NOT used, such as intensive care units (ICU), emergency department (ED), coronary care unit (CCU), post anesthesia care unit (PACU) and in-hospital patient transport. The Airway Adapter is provided in a large size for use with adult/pediatric patients, for connection to the patient's breathing circuit, and may be used with separately supplied gas sample lines. The Airway Adapter is intended for professional use environments and applications specified for the connected respiratory gas modules and patient monitors. The Airway Gas Sampling Products are intended for use by qualified medical personnel only. Prescription use only.

The Bluepoint Medical disposable Airway Gas Sampling Products offered in this submission are specified for use with compatible GE Healthcare side stream respiratory gas modules and patient monitors utilizing these modules. The Airway Gas Sampling Products include two product series: - . Disposable Airway Gas Sampling Sets with airway adapter and integrated side stream TPE gas sampling lines - . Disposable Airway Adapter with female Luer Connector and without sample line The Airway Gas Sampling Sets are offered in both Adult/Pediatric and Infant airway sizes. Two lengths of the Adult/Pediatric size are offered: 3m/10ft, and 2m/7ft. The Infant size is offered in 2m/7ft. The Airway Gas Sampling Sets are constructed with the following features: - . Rigid clear medical grade plastic airway adapter designed for connection to patient breathing circuit - . TPE (thermoplastic elastomer) gas sampling lines with moisture management properties that support their specified use duration of up to 72 hours - . Molded male Luer connector for attachment to GE Healthcare respiratory gas modules The Airway Adapter without sample line is offered in an Adult/Pediatric size, and includes a molded female Luer connector for attachment of a clinician-selected gas sample line. All devices are disposable and labeled for single patient use.

The Nellcor Flexible SpO2 Sensors, models FLEXMAX and FLEXMAX-P, are indicated for use with monitoring systems that use Nellcor OxiMax and Nellcor compatible pulse oximeters. The Nellcor Flexible SpO2 Sensors are intended for use in non-invasive continuous or spot-check monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The sensor size range includes a large and small sensor. The sensors are intended for use on adult and pediatric (excluding infant and neonatal) patients weighing greater than 20kg. The use environment may include: hospital-type facilities, intra-hospital transport, mobile emergency medical applications including both ground and air transport, and home use. Transport environments may include intra-hospital transport and both ground and air emergency transport: road ambulances and fixed-wing aircraft and helicopters. The use is dependent upon the use environments specified for the monitoring system utilized in conjunction with the sensor. The Nellcor Flexible SpO2 Sensors are for prescription use only.

Bluepoint Medical's Nellcor-branded reusable Flexible SpO2 Sensors models FLEXMAX and FLEXMAX-P are pulse oximeter sensors designed and validated for compatibility with Nellcor pulse oximetry and monitoring systems. Bluepoint Medical reusable Nellcor Flexible SpO2 Sensors models FLEXMAX and FLEXMAX-P are designed for the same functionality as the predicate device sensors, measuring functional oxygen saturation using the patient's finger as the measurement site. They are constructed with the following features: - Unitary flexible silicone rubber housing containing the optical transmitter l and detector - . Sensor and cable are immersible for cleaning and disinfection - . Jacketed and shielded medical grade cable with ferrite for EMC suppression - . Manufacturer specific connector with sensor labeling for compatibility with Nellcor pulse oximetry and monitoring systems The reusable Nellcor Flexible SpO2 Sensors are offered in two models corresponding to two sizes: - . FLEXMAX: Reqular Size, with 40 mm housing width - FLEXMAX-P: Small Size, with 38 mm housing width Additionally, two models are packaged specifically for homecare: - . FLEXMAX-HC: Flexible SpO2 finger Sensor, Regular, Homecare - FLEXMAX-P-HC: Flexible SpO2 finger Sensor. Small. Homecare . The homecare sensor models with -HC designation are identical in all respects to their professional use counterparts, however the sensors are packaged to additionally include the Home Use Guide for lay users.