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| 2008® Series Hemodialysis MachinesFresenius Usa, Inc.Haemodialysis system, institutional/home-use | 190904 | Fresenius Usa, Inc. | Haemodialysis system, institutional/home-use |
| 2008® Series Hemodialysis MachinesFresenius Usa, Inc.Haemodialysis system, institutional/home-use | 190395 | Fresenius Usa, Inc. | Haemodialysis system, institutional/home-use |
| CombiSetFresenius Medical Care Holdings, Inc.Haemodialysis blood tubing set, single-use | 03-2962-3 | Fresenius Medical Care Holdings, Inc. | Haemodialysis blood tubing set, single-use |