Inactive
Notice ID:36C25023Q1181
VA-MDNS Category Model INFUSION PUMPS: MULTITHERAPY Alaris Pump Module 8100 INFUSION CONTROLLERS Alaris Pc Unit 8015 NETWORKED SERVERS: MEDICAL Alaris Systems Manager; BD Care Coordination Engine SOFT...
VA-MDNS Category Model INFUSION PUMPS: MULTITHERAPY Alaris Pump Module 8100 INFUSION CONTROLLERS Alaris Pc Unit 8015 NETWORKED SERVERS: MEDICAL Alaris Systems Manager; BD Care Coordination Engine SOFTWARE: MEDICAL Guardrails Editor; CQI Reporter; Alaris System Maintenance Is there a published IFU or public site to download the current SOM for the new 510(K) K211218 requirements for release date June 21, 2023? Not that we are aware of, but you would have to follow up directly with the OEM in this instance. 2.          What is the 8015 PCU firmware version requirement for the new 510(k)? That is between the manufacturer and the FDA. This is something that can be obtained by the OEM as well. 3.          Within the product list, VA Columbus lists BBraun Perfusor Space Syringe Pump. Is the BBraun Syringe pump managed by the Alaris SMS software management system? Is the intent the SMS software management system must control all Infusion Therapeutics Pumps and Data? No. Also no, only the BD Alaris pumps and components.