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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Liquid acid concentrate, 45X, 3K, 2.5Ca, 1 U.S. gallon
Outset Medical, Inc.
PN-0000833
In Commercial Distribution

  • 10850001011058 ()
  • 00850001011051 ()
A-325

  • Haemodialysis concentrate
Liquid bicarbonate concentrate, 45X, 1 U.S. gallon
Outset Medical, Inc.
PN-0000831
In Commercial Distribution

  • 00850001011037 ()
  • 10850001011034 ()
B-100

  • Haemodialysis concentrate
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 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 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 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
Accusol 35 2K+ Solution is indicated for use as dialysis solution in Continuous Renal Replacement Therapy.
Nikkiso Belgium BVBA
35 2K+
Not in Commercial Distribution

  • 09349285000161 ()
  • 19349285000168 ()

  • Total Volume: 2500 Milliliter
5B9249

  • Haemodialysis concentrate
Accusol 35 4K+ Solution is indicated for use as a dialysis solution in Continuous Renal Replacement Therapy.
Nikkiso Belgium BVBA
35 4K+
Not in Commercial Distribution

  • 09349285000154 ()
  • 19349285000151 ()

  • Total Volume: 2500 Milliliter
5B9248

  • Haemodialysis concentrate
Liquid acid concentrate, 45X, 2K, 2.5Ca, 1 U.S. gallon
Outset Medical, Inc.
PN-0000832
In Commercial Distribution

  • 10850001011041 ()
  • 00850001011044 ()
A-225

  • Haemodialysis concentrate
Dialysate Concentrate For Hemodialysis (Liquid or Powder)
Isopure, Corp.
MD70510
In Commercial Distribution

  • 00852456007115 ()


  • Haemodialysis concentrate
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