SAGICO’s Receives FDA Authorization for an ICU Ventilator in Response to the COVID -19 Pandemic

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SAGICO, a US based company providing supply chain solutions and procurement analytics to government healthcare facilities, to produce ventilators in response to the shortage for hospitals.

WWW.SagicoUSA.com

SAGICO, a Florida based medical device company, announced recently that its team of developers and engineers shifted their short term focus during the global COVID-19 pandemic to the production of ventilators in response to the shortage for hospitals. SAGICO provides private and government healthcare facilities with supply chain solutions ranging from spinal implants to eyeglasses and other needed procurements.

The “SAGICO V2O Ventilator” has been cleared by the US Food and Drug Administration (FDA) under the Emergency Use Authorization (EUA). The FDA has determined that the SAGICO V2O SYSTEM model meets the criteria for safety, performance and labeling set forth in Section II and Appendix A of the EUA. As such, the SAGICO V2O SYSTEM is authorized for emergency use in healthcare settings to treat patients during the COVID-19 pandemic, subject to the conditions set forth in the EUA, and has been added to Appendix B of the EUA. The emergency use of the V2O SAGICO SYSTEM under this EUA must be consistent with the terms of the EUA, including the Scope of Authorization (Section II), Conditions of Authorization (Section IV), and Criteria for Safety, Performance and Labeling (Appendix A).

The stated Intended Use is as follows- The SAGICO V20 SYSTEM Ventilator is an electronically controlled, electronically powered machine, which is used in ICU, in Respiratory Department or Emergency Department for the rescue and therapy of the patient with respiratory insufficiency, and in other departments for providing respiratory support for the patient. The SAGICO V20 SYSTEM is to be used only by properly trained healthcare professionals.

Earlier this year and in response to the growing healthcare crisis, SAGICO obtained the permission of the FDA to import the much-needed Class I Personal Protection Equipment (PPE) to include nitrile gloves, N95 and 3-ply surgical face masks, isolation gowns, shoe covers, mattress covers, goggles and face masks. These much needed PPE items are at the front line of defense for healthcare workers and first responders.

MORE ABOUT SAGICO: At SAGICO, we promote the efficiency needed to bridge the divide between cost containment and achieving optimal clinical outcomes. We understand that patient care should be at the forefront of clinical and medical professionals, not procurement of supplies. Often times and at different stages in the supply chain flow many departments tend to be focused on their own independent goals. Providers may want to use a specific product because they were trained with it, whereas hospital executives aim to purchase the most affordable quality items.

The hospital and facilities procurement services offered at SAGICO begins with getting all hospital departments on the same page. This is a key strategy for optimizing healthcare supply chain management. In the era of value-based care, healthcare organizations are focused on reducing redundancies and eliminating waste, but providers also need to work together to effectively reduce costs and boost performance. The team from SAGICO USA promotes efficiency in the healthcare supply chain so facilities can create substantial cost-reducing opportunities across their organization. At SAGICO, we ensure all products meet or exceed all regulatory controls.

SAGICO and its principals have many years of global medical industry success spanning more than 60 countries. SAGICO accomplishes its mission with partners throughout the USA, European, Middle Eastern and PanAsian markets. SAGICO and its affiliates are privately held companies with a global corporate network of shareholders with an aggressive pipeline of various products and offerings.

DISCLOSURE: We at SAGICO are confident in our products and so should our professional surgeons. A surgeon must always rely on his or her own clinical judgment when deciding whether to use a particular medical appliance that may be applicable for a specific patient and adhere to the package insert, product label and/or instructions for use before using any SAGICO product. SAGICO does not diagnose nor does SAGICO offer medical advice on medical conditions and SAGICO requires that all surgeons be trained in the use of any particular product before using it in surgery. The information presented is intended to demonstrate the depth and future of all of SAGICO’s product lines. Some products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact SAGICO prior to any medical procedures to learn more @: http://www.SAGICOUSA.com

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James Gibson
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