WebFeb 19, 2024 · Mount Olive, New Jersey-based Flowonix Medical Inc. said Wednesday that the United States Food and Drug Administration granted approval to market the … WebJan 11, 2024 · The Prometra II pump by Flowonix. The external view of the pump shows the catheter access port (large black arrow in a) and the catheter attachment site (within black circle) as well as the loops to connect the pump to the underling fascia (smaller black arrows in a).An x-ray of the Prometra pump shows the catheter access port (large black …
Prometra Programmable Infusion Pump System – …
WebOct 25, 2024 · Flowonix Medical has won FDA approval for its Prometra II 40 ml programmable pump and its associated software for intrathecal infusion. The pump has expanded reservoir size options that include 20 ml and 40ml pumps, along with the claim of 10-year battery life at average flow rates. Flowonix said in a news release yesterday … WebAug 28, 2024 · Device: Prometra II Programmable Pump - Flowonix Medical The valve gated Prometra II Programmable Pump will be replacing the prior peristaltic Synchromed II pump and a 20% dose decrease will be performed at the time of the replacement. Outcome Measures. Go to rbc signing authority form
Class 2 Device Recall Prometra II Programmable Infusion …
WebFlowonix Medical, Inc. (1) Brand Name. Prometra Refill Kit (1) GMDN Term. General surgical procedure kit, non-medicated, single-use (1) FDA Product Code Name. Pump, Infusion, Implanted, Programmable (1) FDA Product Code. LKK (1) Device Packaged As Sterile. Yes (1) Sterilization Prior To Use. No (1) WebMar 15, 2024 · Flowonix Prometra® II Programmable Pump may require a smaller dose of drug when converting from other commercially available intrathecal drug delivery systems (IDDS). Condition or disease Intervention/treatment ... (Flowonix Medical)' at (refill #1, refill #2, refill #3) and will be compared to retrospectively collected pain (VAS) scores and ... WebThe Refill Kit is indicated for use in patients with a Prometra Programmable Infusion System. It is intended for use in refilling the Drug Reservoir of the Pump. … rbc/sign in