Fresenius Medical Care Renal Therapies Group, LLC

2008T machines: 190766 2008T Hemodialysis System w/Bibag 190895 2008T GEN 2 Bibag without CDX  190766 = 00840861100910 (+Serial Number) 190895 = 00840861100927 (+Serial Number)ux=&Su;

Gastroenterology-Urology Devices

2

No

US Nationwide Distribution

2008T, Hemodialysis Delivery System || Product Indicated for acute and chronic dialysis therapy.

All 132 Gallon Granuflo Dissolution Units and 132 Gallon Dry Acid Dissolution Units with the H218 Motor and Modified H218 Mixer Motors.

Gastroenterology-Urology Devices

2

No

Nationwide Distribution.

Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075. || For Use in the Preparation of acid concentrate for hemodialysis.

All 132 Gallon Granuflo Dissolution Units and 132 Gallon Dry Acid Dissolution Units with the H218 Motor and Modified H218 Mixer Motors.

Gastroenterology-Urology Devices

2

No

Nationwide Distribution.

Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147. || For Use in the Preparation of acid concentrate for hemodialysis.

All 132 Gallon Granuflo Dissolution Units and 132 Gallon Dry Acid Dissolution Units with the H218 Motor and Modified H218 Mixer Motors.

Gastroenterology-Urology Devices

2

No

Nationwide Distribution.

Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. || For Use in the Preparation of acid concentrate for hemodialysis.

Lot # 17KTAC076; UDI-00840861101696

Gastroenterology-Urology Devices

2

No

US Distribution to states of: CA, FL, KS, LA, and TX.

NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 || 3.43 liter bottle || 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.