Address:HOLGER - CRAFOORD - STRASSE 26,HECHINGEN Baden-Wurttemberg,DE
Device Description : The POLyflux LR is intended for use in hemodialysis for the treatment of chronic The POLyflux LR is intended for use in hemodialysis for the treatment of chronic or acute renal failure,The POLyflux LR may be reprocessed for reuse on the same patient
Device Class : 2
Duns Number: 316150549
Premarket Exempt : No
Prescription Use : Yes
Device Description : The POLyflux LR is intended for use in hemodialysis for the treatment of chronic The POLyflux LR is intended for use in hemodialysis for the treatment of chronic or acute renal failure,The POLyflux LR may be reprocessed for reuse on the same patient
Device Class : 2
Duns Number: 316150549
Premarket Exempt : No
Prescription Use : Yes
Device Description : The POLyflux LR is intended for use in hemodialysis for the treatment of chronic The POLyflux LR is intended for use in hemodialysis for the treatment of chronic or acute renal failure,The POLyflux LR may be reprocessed for reuse on the same patient
Device Class : 2
Duns Number: 316150549
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Polyflux 21L is intended for use in haemodialysis for the treatment of chron The Polyflux 21L is intended for use in haemodialysis for the treatment of chronic or acute renal failure
Device Class : 2
Duns Number: 316150549
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Polyflux 210H is intended for use in hemodialysis, hemodiafiltration and hem The Polyflux 210H is intended for use in hemodialysis, hemodiafiltration and hemofiltration for the treatment of chronic or acute renal failure
Device Class : 2
Duns Number: 316150549
Premarket Exempt : No
Prescription Use : Yes
Device Description : The U9000 Ultrafilter is indicated for purification of incoming water for dialys 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.
Device Class : 2
Duns Number: 316150549
Premarket Exempt : No
Prescription Use : Yes
Device Description : Revaclear 300 dialyzer is indicated for treatment of chronic and acute renal fai Revaclear 300 dialyzer is indicated for treatment of chronic and acute renal failure by Hemodialysis.
Device Class : 2
Duns Number: 316150549
Premarket Exempt : No
Prescription Use : Yes
Device Description : Revaclear 400 dialyzer is indicated for treatment of chronic and acute renal fai Revaclear 400 dialyzer is indicated for treatment of chronic and acute renal failure by Hemodialysis
Device Class : 2
Duns Number: 316150549
Premarket Exempt : No
Prescription Use : Yes
Device Description : Device w/ sterile & non-pyrogenic fluid pathways. Expanded HD, w/ Theranova, exp Device w/ sterile & non-pyrogenic fluid pathways. Expanded HD, w/ Theranova, expands the range of molecules efficiently removed during intermittent HD. Dialyzers provide increased removal of various conventional middle (500 Da - <25 kDa) & large middle (25 - 45 kDa) molecules compared to HF membranes. Performances are achieved using existing HD workflow and infrastructure.
Device Class : 2
Duns Number: 316150549
Premarket Exempt : No
Prescription Use : Yes
Device Description : Device w/ sterile & non-pyrogenic fluid pathways. Expanded HD, w/ Theranova, exp Device w/ sterile & non-pyrogenic fluid pathways. Expanded HD, w/ Theranova, expands the range of molecules efficiently removed during intermittent HD. Dialyzers provide increased removal of various conventional middle (500 Da - <25 kDa) & large middle (25 - 45 kDa) molecules compared to HF membranes. Performances are achieved using existing HD workflow and infrastructure.
Device Class : 2
Duns Number: 316150549
Premarket Exempt : No
Prescription Use : Yes