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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Bicarby Dialysate RFP-401
Fresenius Medical Care Renal Therapies Group, LLC
RFP-401-G
In Commercial Distribution

  • 10840861102850 ()
  • 00840861102853 ()

  • Total Volume: 5000 Milliliter


  • Haemodialysis dialysate solution
Bicarby Dialysate RFP-407
Fresenius Medical Care Renal Therapies Group, LLC
RFP-407-G
In Commercial Distribution

  • 10840861102843 ()
  • 00840861102846 ()

  • Total Volume: 5000 Milliliter


  • Haemodialysis dialysate solution
Bicarby Dialysate RFP-400
Fresenius Medical Care Renal Therapies Group, LLC
RFP-400-G
In Commercial Distribution

  • 00840861102839 ()
  • 10840861102836 ()

  • Total Volume: 5000 Milliliter


  • Haemodialysis dialysate solution
Bicarby Dialysate RFP-402
Fresenius Medical Care Renal Therapies Group, LLC
RFP-402-G
In Commercial Distribution

  • 10840861102829 ()
  • 00840861102822 ()

  • Total Volume: 5000 Milliliter


  • Haemodialysis dialysate solution
PureFlow RFP-401
Fresenius Medical Care Renal Therapies Group, LLC
RFP-401-W
In Commercial Distribution

  • 10840861102799 ()
  • 00840861102792 ()

  • Total Volume: 5000 Milliliter


  • Haemodialysis dialysate solution
PureFlow RFP-407
Fresenius Medical Care Renal Therapies Group, LLC
RFP-407-W
In Commercial Distribution

  • 10840861102782 ()
  • 00840861102785 ()

  • Total Volume: 5000 Milliliter


  • Haemodialysis dialysate solution
PureFlow RFP-400
Fresenius Medical Care Renal Therapies Group, LLC
RFP-400-W
In Commercial Distribution

  • 10840861102775 ()
  • 00840861102778 ()

  • Total Volume: 5000 Milliliter


  • Haemodialysis dialysate solution
PureFlow RFP-402
Fresenius Medical Care Renal Therapies Group, LLC
RFP-402-W
In Commercial Distribution

  • 10840861102768 ()
  • 00840861102761 ()

  • Total Volume: 5000 Milliliter


  • Haemodialysis dialysate solution
The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal failure) using Continuous Renal Replacement Therapies, such as continuous hemodialysis and hemodiafiltration aimed at normalizing the composition of the blood. The product may also be used in case of drug poisoning with dialyzable or filterable substances.
BAXTER HEALTHCARE CORPORATION
106957
In Commercial Distribution

  • 50085412645822 ()
  • 00085412645827 ()
106957C

  • Haemodialysis dialysate solution
No Description
NXSTAGE MEDICAL, INC.
RFP-456
In Commercial Distribution

  • M535RFP4565 ()
  • M535RFP4560 ()


  • Haemodialysis dialysate solution
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