Optiflux dialyzer spec sheet
WebOptiflux® F180NR Dialyzer Indications for Use (Describe) Optiflux Dialyzers are intended for patients with acute kidney injury or chronic kidney disease when conservative therapy is judged to be inadequate. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) WebMar 13, 2024 · 510 (k) Number. K192928. Device Name. Optiflux Enexa F500 Dialyzer. Applicant. Fresenius Medical Care Reanal Therapies Group LLC. 920 Winter Street. Waltham, MA 02451. Applicant Contact.
Optiflux dialyzer spec sheet
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WebJun 14, 1993 · SPECIFICATIONS UF-Coefficient (mL/(h*mmHg))* 4854 65 KoA urea* 1186 1439 1578 Blood Compartment volume (mL) 7493 106 Minimum recommended priming volume (mL) 300 Maximum TMP (mmHg) 600 Recommended Q B (mL/min) 200-500200-600250-600 Storage conditions <30°C (or <86°F) Units per box 24 Gross/net weight (g) … WebIndications For Use: Optiflux Dialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. Contraindications: Optiflux dialyzers are not intended for use in patients that weigh less than 30kg.
WebDialyzer Selection for HD (DRAFT November 3, 2024) Page 1 Contents ... clinical specifications (b) contractual obligations for provincial dialyzer utilization; and (c) cost of individual dialyzers. ... Optiflux HF80S Y 1.8 110 55 - … WebOptiflux Dialyzers Manufacturer: Fresenius Medical Care Minimal transfer of endotoxin- and cytokine-inducing substances, by way of back filtration and adsorption from the dialysate compartment to the blood compartment, may lead to reduced inflammation
http://www.bcrenal.ca/resource-gallery/Documents/HD-Dialyzer_Selection_Guideline.pdf Webdialysis with one of three dialyzers: the POLYFLUX and REVACLEAR (PAS-PVP) Dialyzer, Optiflux F160NR (PS-160) dialyzer, or the Optiflux F180NR (PS-180) dialyzer. Patients were excluded if they were younger than 18 years, Veterans Administration beneficiaries, or were on a dialysis modality other than in-center HD. 37,500 U.S. adult hemodialysis
WebOptiflux Enexa F500 Dialyzer Common Name: Dialyzer Regulation Name: High permeability hemodialysis system Regulatory Class: Class II per 21 CFR §876.5860 Product Code: KDI Product Code Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System Classification Panel: Gastroenterology/Urology 5.3. Legally Marketed Predicate Device
WebOptiflux High Flux Specifications - Fresenius Medical Care flint original coney sauceWebThis item may require 1-2 days to ship out from our facility.Product Information: F160NRe Optiflux Dialyzer, E-Beam Sterilized, Labeled, Single UseManufacturer Part # 0500316EDescription Minimal transfer of endotoxin- and cytokine-inducing substances, by way of back filtration and adsorption from the dialysate compartm greater peoria obgynWebThe Optiflux dialyzers are manufactured from Advanced Fresenius Polysulfone, polycarbonate, polyurethane and silicone. The Optiflux dialyzer are classified as an external communicating... greater peoria sanitary ez payWebIndications for use: Optiflux F160NRe, F180NRe, F200NRe, and F250NRe dialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. The suitability of a dialyzer for a particular treatment is the responsibility of the physician. greater peoria specialty hospital ilWebThe Optiflux F180NR dialyzer is the subject of this 510(k). 5.4.2. Device Characteristics The Optiflux F180NR dialyzer is a high-flux, single-use, ethylene oxide (EO) sterilized hemodialyzer. The dialyzer is provided blood pathway sterile and non-pyrogenic. The membrane surface area is 1.7 m2. Confidential & Proprietary. K192707 page 1 of 5 greater periwinkle globallyWebOct 28, 2024 · The dialyzer was the Phylther HF20SD (a 2.0m2 heat sterilized high flux (HF) polyphenylene membrane from Bellco). At the initiation of dialysis, the serum albumin was 4.0 g/dl. During the following months, the patient developed severe hypoalbuminemia. The lowest value observed was 2.26 g/dl in July 2024. greater peoria sanitary district paymentWebOptiflux F200A 0500320A case 12/case Dialyzer Part Number Unit Quantity/Case Low Flux (single-use labeled) Optiflux F16NRe 0500306E case 12/case Optiflux F18NRe 0500308E case 12/case High Flux (single-use labeled, electron beam sterilized) Optiflux F160NRe 0500316E case 12/case Optiflux F180NRe 0500318E case 12/case greater peoria specialty hospital