Covidien Announces FDA 510(k) Clearance of the Nellcor Bedside SpO2 Patient Monitoring System

Enhanced Features Enable Rapid Clinician Response to Subtle yet Critical Heart Rate and Oxygen Saturation (SpO2) Changes

BOULDER, Colo.--()--Covidien (NYSE: COV), a leading global provider of healthcare products and recognized innovator in patient monitoring and respiratory care solutions, today announced the U.S. Food and Drug Administration (FDA) has granted the Company 510(k) clearance to market the Covidien Nellcor Bedside SpO2 Patient Monitoring System. The new patient monitoring system is now available for sale in the U.S.

The Nellcor Bedside SpO2 system with OxiMax technology continuously monitors SpO2 and pulse rate for adult, pediatric and neonatal patients, giving clinicians instant access to comprehensive trending respiratory information. This enables clinicians to detect subtle, yet critical, heart rate and SpO2 variations earlier and thus address respiratory complications sooner.

“We are pleased to announce the new Covidien Nellcor Bedside SpO2 Patient Monitoring System is approved for commercial release in the United States,” said Robert J. White, President, Respiratory and Monitoring Solutions, Covidien. “Healthcare professionals on the general care floor, and in other lower- acuity areas of the hospital, need critical patient information at their fingertips so they can respond quickly to health threats. By giving them ready access to a patient’s respiratory history, the system allows them to focus on delivering efficient, high-quality care, not gathering and managing data.”

The Nellcor Bedside SpO2 Patient Monitoring System also features enhanced digital signal processing for precise SpO2 readings during low perfusion or other challenging conditions that make it difficult to accurately track these patients. Its SatSeconds alarm management technology differentiates between serious and minor events to reduce clinically insignificant oxygen desaturation alarms. The monitor further offers an intuitive, multicolor screen that is easy to read in any light and from many angles. Additionally, hospital technicians can set institutional defaults, replace the battery, perform diagnostics and generally maintain the monitor within the hospital, saving time and resources.

The Nellcor Bedside SpO2 Patient Monitoring System meets medical electrical equipment safety standards, including IEC 60601-1:2005, and complies with the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS) directive for products sold in European Economic Area markets.

ABOUT COVIDIEN

Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2011 revenue of $11.6 billion, Covidien has 43,000 employees worldwide in more than 65 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business.

Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50357234&lang=en

Contacts

Covidien
Rhonda Luniak, 303-305-2263
Vice President
R&MS Communications
rhonda.luniak@covidien.com
or
Bruce Farmer, 508-452-4372
Vice President
Public Relations
bruce.farmer@covidien.com
or
Coleman Lannum, CFA, 508-452-4343
Vice President
Investor Relations
cole.lannum@covidien.com
or
Todd Carpenter, 508-452-4363
Director
Investor Relations
todd.carpenter@covidien.com

Covidien Announces FDA 510(k) Clearance of the Nellcor(TM) Bedside SpO2 Patient Monitoring System (Photo: Business Wire)

Covidien Announces FDA 510(k) Clearance of the Nellcor(TM) Bedside SpO2 Patient Monitoring System (Photo: Business Wire)

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Contacts

Covidien
Rhonda Luniak, 303-305-2263
Vice President
R&MS Communications
rhonda.luniak@covidien.com
or
Bruce Farmer, 508-452-4372
Vice President
Public Relations
bruce.farmer@covidien.com
or
Coleman Lannum, CFA, 508-452-4343
Vice President
Investor Relations
cole.lannum@covidien.com
or
Todd Carpenter, 508-452-4363
Director
Investor Relations
todd.carpenter@covidien.com