Search Results

The DEKA Infusion System is indicated for continuous delivery of general maintenance fluids and supported antibiotics to adult patients through a peripheral intravenous (IV) site under the supervision of a qualified clinician. The DEKA Administration Set is indicated for gravity administration of general maintenance fluids and supported antibiotics approved for peripheral intravenous (IV) infusion to adult patients under the supervision of a qualified clinician. The DEKA Administration Set is indicated for single patient use only. The DEKA Administration Set is not indicated for administration of high-alert medications, blood, and blood products. The DEKA Administration Set is compatible with the DEKA Infusion Controller or can be used as a stand-alone administration set for performing manual gravity infusions.

The subject device is a modified version of the predicate DEKA Infusion System. Updates have been made to the predicate device software to increase the maximum programmable flow rate (from 300 to 600 mL/h), update the labeling to reflect the increased maximum programmable flow rate and update the performance of tilt angle detection. The administration set is unchanged. The DEKA Infusion System, comprised of the DEKA Infusion Controller and DEKA Administration Set, is a gravity-based infusion controller. The Infusion Controller uses a camera to view drop formation in an Administration Set Drip Chamber in order to measure flow rate. During an infusion, the Infusion Controller can adjust the Flow Control Valve (FCV) as necessary against the DEKA Administration Set to maintain the desired flow rate without user intervention. The DEKA Administration Set is a single-use, non-DEHP intravascular administration set provided sterile. It is compatible with the DEKA Infusion Controller or can be used as a standalone administration set for performing manual gravity infusions.

The DEKA Infusion System is indicated for continuous delivery of general maintenance fluids and supported antibiotics to adult patients through a peripheral intravenous (IV) site under the supervision of a qualified clinician. The DEKA Administration Set is indicated for gravity administration of general maintenance fluids and supported antibiotics approved for peripheral intravenous (IV) infusion to adult patients under the supervision of a qualified clinician. The DEKA Administration Set is indicated for single patient use only. The DEKA Administration Set is not indicated for administration of high-alert medications, blood, and blood products. The DEKA Administration Set is compatible with the DEKA Infusion Controller or can be used as a stand-alone administration set for performing manual gravity infusions.

The DEKA Infusion System, comprised of the DEKA Infusion Controller and DEKA Administration Set, is a gravity-based infusion controller. The Infusion Controller uses a Camera to view drop formation in an Administration Set Drip Chamber in order to measure flow rate. During an infusion, the Infusion Controller can adjust the Flow Control Valve (FCV) as necessary against the DEKA Administration Set to maintain the desired flow rate without user intervention. The DEKA Administration Set is a single-use, non-DEHP intravascular administration set provided sterile. It is compatible with the DEKA Infusion Controller or can be used as a standalone administration set for performing manual gravity infusions.

The Volumetric Infusion Controller is intended for the delivery of general maintenance fluids and non-critical antibiotics to adult patients using gravity infusion in a clinical setting by a trained medical professional. The device is not intended to administer critical fluids, including high-risk medications.

The Volumetric Infusion Controller (VIC) is a gravity-based electronic infusion controller relying on head height to provide the delivery pressure necessary to meet the target infusion delivery rates. The drip chamber of an administration set is monitored by a vision system for drop growth. This information is used to provide feedback to the flow control valve to establish and maintain the target flow-rate without user intervention.

The Pacer Model 100 Infusion Controller is indicated for use in: - 1. The delivery if Intravenous (parenteral) fluids where positive pressure (above 36" of water) is not required. - 2. The delivery of intravenous drugs where positive pressure (above 36" of water) is not required.

Not Found

Replacement battery for IVAC Corp. 123233 230, 600 Infusion Controller, 510(k) Number K884307. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.

Not Found

Replacement battery for IVAC Corp. 123233, 41B905KD10-1 230 Infusion Controller, 510(k) Number KR84307 K884307. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitions only contrience with the replacement battley of to pancellar device of to intended use is a replacement hattery. The biomedical equipment technician t intended use is as a replacement battery.

Not Found