| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 9611369 | 3002807035 | GAMBRO DIALYSATOREN GMBH | 1 | N | 2026-01-01 | HOLGER - CRAFOORD - STRASSE 26 HECHINGEN Baden-Wurttemberg DE 72379 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 07332414031770 | POLYFLUX - Polyflux R is intended for use in hemodialysis for the treatment of chronic and acute renal failure Polyflux R may be reprocessed for reuse on the same patient | +1(800)933-0303 | Medinfo_medproducts@baxter.com |
| 07332414031787 | POLYFLUX - Polyflux R is intended for use in hemodialysis for the treatment of chronic and acute renal failure Polyflux R may be reprocessed for reuse on the same patient | +1(800)933-0303 | Medinfo_medproducts@baxter.com |
| 07332414036140 | POLYFLUX - Polyflux R is intended for use in hemodialysis for the treatment of chronic and acute renal failure Polyflux R may be reprocessed for reuse on the same patient | +1(800)933-0303 | Medinfo_medproducts@baxter.com |
| 07332414036416 | Polyflux - The Polyflux 17L is intended for hemodialysis, for the treatment of chronic or acute renal failure | +1(800)933-0303 | Medinfo_medproducts@baxter.com |
| 07332414036423 | Polyflux - The Polyflux 14L capillary dialyzer is intended for use in haemodialysis for the treatment of chronic and acute renal failure. | +1(800)933-0303 | Medinfo_medproducts@baxter.com |
| 07332414037925 | Polyflux - The Polyflux 140H is intended for use in hemodialysis, hemodiafiltration and hemofiltration for the treatment of chronic or acute renal failure | +1(800)933-0303 | Medinfo_medproducts@baxter.com |
| 07332414102500 | Ultrafilter U 9000 - The U9000 Ultrafilter is indicated for purification of incoming water for dialysis fluid as well as purification of dialysis fluid to obtain microbiological high quality dialysis fluid. The risk of exposure to bacteria and endotoxins can thereby be minimized. | +1(800)933-0303 | medinfo_medproducts@baxter.com |
| 07332414126957 | U9000 Plus ultrafilter - The U9000 Plus Ultrafilter is indicated for purification of incoming water for dialysis fluid as well as purification of dialysis fluid to obtain microbiological high quality dialysis fluid. The risk of exposure to bacteria and endotoxins can thereby be minimized. | +1(800)933-0303 | medinfo_medproducts@baxter.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 18600 | 1634180848 | K873643 | GAMBRO ADSORBA 150C | FLD | 1987-12-29 |
| 18600 | 1673036134 | K213639 | Revaclear 500, Revaclear 400, Revaclear 300 | KDI | 2022-01-24 |
| 18600 | 1445837300 | K211035 | U9000 Plus Ultrafilter | FIP | 2021-10-19 |
| 18600 | 1483072827 | K201809 | AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory | KDI | 2021-03-10 |
| 18600 | 1848042131 | K133807 | MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT | FLD | 2014-03-26 |
| 18600 | 1142140372 | K130039 | REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER | KDI | 2013-05-02 |
| 18600 | 1032695987 | K051520 | GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H | KDI | 2005-12-09 |
| 18600 | 2071852981 | K043342 | POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR | FJI | 2005-05-27 |
| 18600 | 1619075872 | DEN190042 | Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer | QAX | 2020-08-28 |
| 18600 | 1045741721 |
2021-03-31
2021-12-30
2015-10-12
2015-10-12
2015-10-12
2015-10-08
2015-10-12
2015-10-12
2015-10-12
2015-10-12
2015-10-12
2015-10-12
2015-10-12
2015-10-12
2015-10-12
2015-10-12
2021-11-08
2021-11-08
2016-09-24
2016-09-24
2015-10-12
2020-09-02
2020-10-26
2021-12-30
2021-11-08
2021-11-08
2021-03-31
2020-10-26
2020-09-02
2016-09-24
2015-10-12
2015-10-12
2015-10-12
2015-10-12
2015-10-08
2015-10-12
2015-10-12
2015-10-12
2015-10-12
2015-10-12
baxter.com