FDA-Device2014-06-18Class III
NaturaLyte¿ Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part Number: 08-4000-LB. The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
Fresenius Medical Care Holdings, Inc.
Hazard
Container cap may contain foreign material- 0.60% - 0.80% Manganese
Sold states
Distributed in the state of MO.
Affected count
12 bottles
Manufactured in
920 Winter St, N/A, Waltham, MA, United States
Products
NaturaLyte¿ Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part Number: 08-4000-LB. The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1739-2014Don't want to check this manually?
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