NaturaLyte Liquid Acid Concentrate

Lot Number: 15STAC072 Exp Date: 2017-12-31

Gastroenterology-Urology Devices

2

No

US Distribution to states of: KS, LA, MS, OK, and TX.

Fresenius Naturalyte Liquid Acid Concentrate || Catalog Number: 08-2301-3 || Intended Use: Acid Concentrate for Bicarbonate Dialysis

Lot Code: 18CXAC095

Gastroenterology-Urology Devices

2

No

Worldwide Distribution - US Nationwide in the states: CA, IA, IL, IN, KS, MD, MI, MN, MS, NE, NJ, NV, OK, PA, SD, TX, and WI.

NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 || Product Usage: || This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine. For every 45 volume parts of dialysate: 1 volume part of the NaturaLyte acid concentrate, 1.72 volume parts of FMCNA Sodium Bicarbonate Concentrate and 42.28 volume parts of Purified Water (AAMI quality) are used.

Medical Device Safety Alert: Fresenius Naturalyte Liquid Acid Concentrate and Naturalyte GranuFlo (powder) Acid Concentrate

All lots

Gastroenterology-Urology Devices

2

No

Nationwide Distribution and the country of Guam.

Fresenius NaturaLyte Liquid Acid Concentrate || Product Codes: || 08-0231-4, 08-1001-0, 08-1201-8, 08-1231-3, 08-1251-1, 08-1301-4, 08-2201-5, 08-2231-2, 08-2251-0, 08-2301-3,08-2351-8,08-3201-4,08-3231-1,08-3251-9,08-3301-2,08-4123-1, 08-4223-7, 08-4225-1' 08-4230-2, 08-4231-0, 08-4323-5, 08-4325-1, 13-1251-1, 13-2201-5, 13-2231-2, 13-2251-0, || 13-3231-1,13-3251-9, 13-4123-1' 13-4220-1, 13-4225-1 ' 13-4325-1. || For the treatment of acute and chronic renal failure during hemodialysis procedure.