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1523 E MARCH LN, STE 200, STOCKTON, CA, 95210 PR0529829 <br /> April 26, 2022 Program: HMBP <br /> PHOTO#9 <br /> Label on container of li uid acid concentrate. <br /> r <br /> Catalog No. Nionical Nom rtat <br /> ♦ Fina <br /> 2 O OQ_n301 _� Contribution Dialysate <br /> ,` v L to Dialysate Composi ion <br /> FORUSE SODIUM 100 mEq/L 137 mEq/L <br /> �a Liquid Acid Concentrate is indicated for use in POTASSIUM 2.0 mE /L 2.0 MEWL <br /> ung extracorporeal bicarbonate hemodialysis for q �L <br /> d chronic renal failure. NATURALYTE Liquid Acid CALCIUM 1.0 mEgIL 3.0 mEgIL <br /> "hate is intended to be used as one component in the MAGNESIUM 1.0 mEgIL 1.0 mEq/L <br /> of dialysate in a three-stream proportioning ACETATE 4.0 mEq/L 4.0 mEq/L <br /> ,k, rs machine according to a physician's prescription. CHLORIDE 106.0 mEgIL 106.0 mEgIL <br /> 7-�L�,tlrienjttojr <br /> NG DEXTROSE 100 m /dL 100m g/dL <br /> low theseInstructions for Use may result in BICARBONATE* qr death. *Post reaction Bicarbonate <br /> ,���k conductivity and pH of final dialysate prior to dialysis Nominal Chemical Composition <br /> Ntment and each time new concentrate is supplied to the 263 g/L NaCl, 6.71 g/L KCI, 7.49 g/L Co.. <br /> racnme. Refer to hemodialysis machine manufacturer's 214 /L M CI 10.8 g/L CH 002H, 45.0 yL Dextrose <br /> �strdonsto determine conductivi and pH of final dialysate. g MgC12' s <br /> • ^ts product contains acetic acid and yields 4 mEq/L of REQUIREMENTS <br /> acetate in the final dialysate. Following diffusion from the For use only with a three-stream hemodialysis <br /> diah sate across the dialysis membrane to the blood,acetate is machine calibrated to proportion 1 part acid to 1.72 <br /> metabolized to bicarbonate.While the acetate from the acid parts bicarbonate concentrate to 42.28 parts purified <br /> o nentrate will contribute to the serum bicarbonate level,the water that meets ISO 13959 or AAMI RD62 water <br /> semm bicarbonate level of the patient during and immediately quality requirements.Use only with 45X bicarbonate <br /> atter the dialysis treatment is principally ,etermined by the (�B')concentrates. <br /> preschbeyydssbicarbonate concentration which is set on the onate STORAGEANDDISPOSAL <br /> rray�conitribute to metabolic acidostion is;ex ess ve bicarent bonate Store between 5°C and 30°C (41°F and 86°F). <br /> may contribute to metabolic alkalosis. Both conditions are Product can withstand an exposure to temperatures <br /> associated with poor patient outcomes. down to 0°C and up to 40°C(32°F to 104°F)for a <br /> S�AUTION period of up to 72 hours. Mix thoroughly before <br /> use. Keep container sealed when not in use. <br /> •Federal law(U.S.A.)restricts this device to sale by or on the Dispose of unused concentrate in accordance with <br /> order of a physician. local,state,and federal regulations. <br /> Wear safety lasses, loves and clothing suitable to prevent Manufaswrer <br /> g g FRESENIUS Fresenius Medical care <br /> exposure when handling.Acid concentrate can irritate eyes and skin. r <br /> MEDICAL CARE Caitl' VIA 024z)i°USA <br /> •Do not use rf package is damaged or seal is broken. RENS THERAPIES GROUP <br /> 1!" <br /> 800 323-51 as <br /> Patents apply,visit www.fmcna.com/patents <br /> I i i„ ���C�O <br /> 0a <br /> 08-2301-3 11 ( 01) 008408611017'"- a <br /> Vr,�• • ( 17 11, 231231 <br /> rw.Cwe: 2023 - 12 - 31 f. . fF <br /> Ih `,* ( 10) 21STAC003 <br /> '' 21 S T A C 0 0 3 pr,1e, ,U9A 71-4319 06 10 18 <br /> A <br /> Robert Lopez, EHS Page 9 of 10 <br />