There are 2,950 Direct US and US territory Customers. Product shave also been distributed to Canada, Europe, Japan, Latin America and Australia.
Description du dispositif
Nellcor brand Pulse Oximeter, model N-395, || Made in Ireland; Distributed by Tyco Healthcare Group, LP, Nellcor Puritan Bennett, Inc., Pleasanton, CA 94588 U.S.A.
Concerning the batteries of the Capnostream 20 and Capnostream 20p reference equipment, manufactured between April 2014 and February 2016.
Description du dispositif
Continuously monitor the carbon dioxide at the end of the respiration, the respiratory rate, the fractional inspiratory carbon dioxide, the oxygen saturation and the heart rate.
Nationwide. Foreign: Belgium Germany France Netherlands
Description du dispositif
Covidien Nellcor SpO2 Forehead Sensor || Item Code: RS10; || The Covidien Nellcor¿ Forehead SpO2Sensor, model RS10, is indicated for use when continuous non-invasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing more than 40 kg.
The firm has distributed the sensors to 1 researcher in Europe, and 68 to direct customers (medical facilities) and 112 Field Sales Reps. Currently, there are no finished goods at the manufacturing site. 655 cases of product were disposed of at the distribution facility due to product expiration. The firm estimates 442 cases (3,536 units) to be in distribution channels.
Description du dispositif
The probes involved have been part of the Nellcor¿ CapnoProbeTM SLS~1 Sublingual System. The CapnoProbe system consists of an N-80 CapnoProbe device and an SLS-1 Sublingual Sensor, or probe. Each probe is packaged in a metal canister filled with a nonsterile buffered saline solution. The canister is in a sealed foil envelope. Each disposable probe is used only one time.