Baxter Announces U.S. FDA Clearance of Novum IQ Large Volume Infusion Pump and Dose IQ Safety Software, Advancing Connected and Intelligent Infusion Therapy - Seite 3

Novum IQ Syringe Pump Indications for Use

The Novum IQ syringe pump is intended to be used for the controlled administration of fluids. These include pharmaceutical drugs, parenteral nutrition, blood and blood products, and enteral nutrition. The Novum IQ syringe pump is intended to deliver an infusion through the following clinically accepted routes of administration: intravenous, arterial, enteral, and subcutaneous. The Novum IQ syringe pump is intended to be used in conjunction with legally marketed and compatible administration sets, syringes, and medications provided by the user. The Novum IQ syringe pump is suitable for patient care in hospitals and outpatient health care facilities. The Novum IQ syringe pump is intended for use on adults, pediatrics and neonates. The Novum IQ syringe pump is intended to aid in the reduction of operator interaction through guided programming, including a way to automate the programming of infusion parameters and documentation of infusion therapies when integrated with an Electronic Medical Record (EMR) system. This automation is intended to aid in the reduction of programming errors. The Novum IQ syringe pump is intended to be used by trained healthcare professionals.

Dose IQ Safety Software for Novum IQ LVP and Syringe Pump Indications for Use

Dose IQ Safety Software is intended to be used with the Novum IQ Syringe Pump and Novum IQ Large Volume Pump to support the controlled administration of fluids. Dose IQ Safety Software is intended to allow users to create and maintain drug libraries, including the configuration of pump settings for the compatible pumps. Dose IQ Safety Software is intended to allow users to establish the facility-defined syringe list, which is a subset of Baxter’s approved compatible syringes, for the Novum IQ Syringe Pump. Dose IQ Safety Software is intended to be used by licensed pharmacists. Dose IQ Safety Software is intended to be used in hospitals and outpatient health care facilities.

Rx only. For safe and proper use of the products mentioned herein, please refer to the appropriate Operators Manual.

This release includes forward-looking statements concerning Novum IQ, Dose IQ and IQ Enterprise, including potential benefits associated with their use. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: demand for and market acceptance for new and existing products; product development risks, including satisfactory clinical performance and obtaining and maintaining required regulatory approvals (including as a result of evolving regulatory requirements); breaches or failures of or vulnerabilities in the company's information technology systems or products, including by cyber-attack, data leakage, unauthorized access or theft; product quality, manufacturing or supply, or patient safety issues; inability to create additional production capacity in a timely manner or the occurrence of other manufacturing or supply difficulties (including as a result of natural disasters, public health crises and epidemics/pandemics, regulatory actions or otherwise); actions of regulatory bodies and other governmental authorities; changes in law and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements unless otherwise required by the federal securities laws.