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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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Citrasate - 00840861101368

Citrasate Liquid Acid Concentrate for Bicarbonate Dialysis, Drum
Fresenius Medical Care Renal Therapies Group, LLC
13-1251-CA
In Commercial Distribution

  • 00840861101368 ()
13-1251-CA

  • Haemodialysis concentrate

Citrasate - 00840861101351

Citrasate Liquid Acid Concentrate for Bicarbonate Dialysis, Case
Fresenius Medical Care Renal Therapies Group, LLC
08-3251-CA
In Commercial Distribution

  • 10840861101358 ()
  • 00840861101351 ()
08-3251-CA

  • Haemodialysis concentrate

Citrasate - 00840861101344

Citrasate Liquid Acid Concentrate for Bicarbonate Dialysis, Case
Fresenius Medical Care Renal Therapies Group, LLC
08-2251-CA
In Commercial Distribution

  • 10840861101341 ()
  • 00840861101344 ()
08-2251-CA

  • Haemodialysis concentrate

Citrasate - 00840861101337

Citrasate Liquid Acid Concentrate for Bicarbonate Dialysis, Case
Fresenius Medical Care Renal Therapies Group, LLC
08-1251-CA
In Commercial Distribution

  • 10840861101334 ()
  • 00840861101337 ()
08-1251-CA

  • Haemodialysis concentrate

Bibag - 00840861101320

Bibag Dry Sodium Bicarbonate
Fresenius Medical Care Holdings, Inc.
08-4080-BB
In Commercial Distribution

  • 10840861101327 ()
  • 00840861101320 ()
08-4080-BB

  • Haemodialysis concentrate

Bibag - 00840861101313

Bibag Dry Sodium Bicarbonate
Fresenius Medical Care Holdings, Inc.
08-4078-BB
In Commercial Distribution

  • 10840861101310 ()
  • 00840861101313 ()
08-4078-BB

  • Haemodialysis concentrate

Premixed Dialysate for Hemodiafiltration - 09349285000208

Premixed Dialysate for Hemodiafiltration is indicated for acute dialysis modalities that employ hemodiafiltration, such as continuous arteriovenous hemodiafiltration (CAVHD) and Continuous Venous-Venous Hemodiafiltration (CVVHD), when treatment of actue renal failure patients with hypervolemia and uremia requires high solute clearance.
Nikkiso Belgium BVBA
5B7860
Not in Commercial Distribution

  • 19349285000205 ()
  • 09349285000208 ()

  • Total Volume: 5000 Milliliter
5B7860

  • Haemodialysis concentrate

ACCUSOL Dialysis Solution for CRRT - 09349285000192

Accusol 30 2K+ 0Ca++ Solution is indicated for use as dialysis solution in Continuous Renal Replacement Therapy.
Nikkiso Belgium BVBA
30 2K+ 0Ca++
Not in Commercial Distribution

  • 09349285000192 ()
  • 19349285000199 ()

  • Total Volume: 2500 Milliliter
5B9252

  • Haemodialysis concentrate

ACCUSOL Dialysis Solution for CRRT - 09349285000185

Accusol 30 2K+ Solution is indicated for use as dialysis solutions in Continuous Renal Replacement Therapy.
Nikkiso Belgium BVBA
30 2K+
Not in Commercial Distribution

  • 19349285000182 ()
  • 09349285000185 ()

  • Total Volume: 2500 Milliliter
5B9251

  • Haemodialysis concentrate

ACCUSOL Dialysis Solution for CRRT - 09349285000178

Accusol 35 0K+ 0DEX Solution is indicated for use as dialysis solution in Continuous Renal Replacement Therapy.
Nikkiso Belgium BVBA
35 0K+ 0DEX
Not in Commercial Distribution

  • 09349285000178 ()
  • 19349285000175 ()

  • Total Volume: 2500 Milliliter
5B9250

  • Haemodialysis concentrate
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