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

  • 00850001011037 ()
  • 10850001011034 ()
B-100

  • Haemodialysis concentrate
Duosol™ Bicarb 25 Dialysate K2/Ca0 2x5000 mL (4553)
B. BRAUN MEDICAL INC.
4553
In Commercial Distribution

  • 04039239088295 ()
  • 04039239088288 ()

  • Ca++ concentration (mEq/L) : 0.000 MEQ
  • K+ concentration (mEq/L) : 2.000 MEQ
  • Volume : 5000.000 ML
  • HCO3- concentration (mEq/L) : 25.000 MEQ
4553

  • Haemodialysis concentrate
Duosol™ Bicarb 35 Dialysate K0/Ca3 2X5000 ML (4551)
B. BRAUN MEDICAL INC.
4551
In Commercial Distribution

  • 04039239085089 ()
  • 04039239084990 ()

  • HCO3- concentration (mEq/L) : 35.000 MEQ
  • Ca++ concentration (mEq/L) : 3.000 MEQ
  • K+ concentration (mEq/L) : 0.000 MEQ
  • Volume : 5000.000 ML
4551

  • Haemodialysis concentrate
Duosol™ Bicarb 35 Dialysate K2/Ca32x5000 mL (4552)
B. BRAUN MEDICAL INC.
4552
In Commercial Distribution

  • 04039239085010 ()
  • 04039239085003 ()

  • K+ concentration (mEq/L) : 2.000 MEQ
  • Ca++ concentration (mEq/L) : 3.000 MEQ
  • Volume : 5000.000 ML
  • HCO3- concentration (mEq/L) : 35.000 MEQ
4552

  • Haemodialysis concentrate
NaturaLyte Dry Pack Sodium Bicarbonate RX 12
Fresenius Medical Care Holdings, Inc.
08-4112-2
In Commercial Distribution

  • 00840861101955 ()
08-4112-2

  • Haemodialysis concentrate
NaturaLyte Liquid Sodium Bicarbonate, Case
Fresenius Medical Care Holdings, Inc.
08-4000-LB 6.4L
In Commercial Distribution

  • 10840861101938 ()
  • 00840861101931 ()
08-4000-LB

  • Haemodialysis concentrate
NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, Drum
Fresenius Medical Care Renal Therapies Group, LLC
13-3231-1
In Commercial Distribution

  • 00840861101870 ()
13-3231-1

  • Haemodialysis concentrate
NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, Drum
Fresenius Medical Care Renal Therapies Group, LLC
13-2201-5
In Commercial Distribution

  • 00840861101849 ()
13-2201-5

  • Haemodialysis concentrate
NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, Case
Fresenius Medical Care Renal Therapies Group, LLC
08-4231-0
In Commercial Distribution

  • 10840861101808 ()
  • 00840861101801 ()
08-4231-0

  • Haemodialysis concentrate
NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, Case
Fresenius Medical Care Renal Therapies Group, LLC
08-3251-9
In Commercial Distribution

  • 10840861101747 ()
  • 00840861101740 ()
08-3251-9

  • Haemodialysis concentrate
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