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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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
Duosol™ Bicarb 25 Dialysate K4/Ca0 2X5000 mL (4556)
B. BRAUN MEDICAL INC.
4556
In Commercial Distribution

  • 04046963563929 ()
  • 04046963563912 ()

  • HCO3- concentration (mEq/L) : 25.000 MEQ
  • Volume : 5000.000 ML
  • K+ concentration (mEq/L) : 4.000 MEQ
  • Ca++ concentration (mEq/L) : 0.000 MEQ
4556

  • Haemodialysis concentrate
Duosol™ Bicarb 32 Dialysate K2/Ca0 2x5000 mL (4554)
B. BRAUN MEDICAL INC.
4554
In Commercial Distribution

  • 04046963112202 ()
  • 04046963112196 ()

  • HCO3- concentration (mEq/L) : 32.000 MEQ
  • Ca++ concentration (mEq/L) : 0.000 MEQ
  • Volume : 5000.000 ML
  • K+ concentration (mEq/L) : 2.000 MEQ
4554

  • Haemodialysis concentrate
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 450 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055445009
In Commercial Distribution

  • 08426950807803 ()
00055445009

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 300 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055430009
In Commercial Distribution

  • 08426950807742 ()
00055430009

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 150 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055415009
In Commercial Distribution

  • 08426950807681 ()
00055415009

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 75 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055407509
In Commercial Distribution

  • 08426950807629 ()
00055407509

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 600 Test 21 Days
INSTRUMENTATION LABORATORY COMPANY
00055360009
In Commercial Distribution

  • 08426950807582 ()
00055360009

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glu, Lac, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 600 Test 21DAY
INSTRUMENTATION LABORATORY COMPANY
00027360010
In Commercial Distribution

  • 08426950465379 ()
00027360010

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glu, Lac, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 75 Test 30DAY
INSTRUMENTATION LABORATORY COMPANY
00027407510
In Commercial Distribution

  • 08426950461081 ()
00027407510

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glu, Lac, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 450 Test 30DAY
INSTRUMENTATION LABORATORY COMPANY
00027445010
In Commercial Distribution

  • 08426950441304 ()
00027445010

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glu, Lac, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 150 Test 30DAY
INSTRUMENTATION LABORATORY COMPANY
00027415010
In Commercial Distribution

  • 08426950440703 ()
00027415010

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glu, Lac, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 300 Test 30DAY
INSTRUMENTATION LABORATORY COMPANY
00027430010
In Commercial Distribution

  • 08426950440697 ()
00027430010

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
PRIMARY DRESSING WOUND CARE STERILE SQUARE CALCIUM ALGINATE FIBER OFF WHITE CA/100 CALCIUM ALGINATE FIBER Not made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
50100
In Commercial Distribution

  • 30885632403839 ()
  • 10885632403835 ()
  • 20885632403832 ()


  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
PRIMARY DRESSING WOUND CARE STERILE RIBBON CALCIUM ALGINATE FIBER OFF WHITE CA/50 CALCIUM ALGINATE FIBER Not made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
50099
In Commercial Distribution

  • 20885632403825 ()
  • 30885632403822 ()
  • 10885632403828 ()


  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
PRIMARY DRESSING WOUND CARE STERILE RECTANGE CALCIUM ALGINATE FIBER OFF WHITE CA/50 CALCIUM ALGINATE FIBER Not made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
50098
In Commercial Distribution

  • 20885632403818 ()
  • 30885632403815 ()
  • 10885632403811 ()


  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
PRIMARY DRESSING WOUND CARE STERILE SQUARE CALCIUM ALGINATE FIBER OFF WHITE CA/100 CALCIUM ALGINATE FIBER Not made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
50097
In Commercial Distribution

  • 20885632403801 ()
  • 30885632403808 ()
  • 10885632403804 ()


  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Blood Culture Transfer Device Female Luer Lock Connector Standard Polypropylene Light Blue Single Use CA/60 Not made with Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
50015
In Commercial Distribution

  • 20885632401364 ()
  • 10885632401367 ()


  • Non-fixed blood collection needle
Blood Culture Transfer Device Male Luer Lock Connector Standard Polypropylene Light Blue Single Use CA/60 Not made with Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
50014
In Commercial Distribution

  • 20885632401357 ()
  • 10885632401350 ()


  • Non-fixed blood collection needle
Glove Exam Nitrile Ice Blue 3.5g Xlarge Powder Free Textured Finger 100Ea/Bx 10Bx/CA Non-Sterile Not Made with Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
GLV2704
In Commercial Distribution

  • 30885632291658 ()
  • 20885632291651 ()
  • 10885632291654 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Glove Exam Nitrile Ice Blue 3.5g Large Powder Free Textured Finger 100Ea/Bx 10Bx/Ca Non-Sterile Not Made with Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
GLV2703
In Commercial Distribution

  • 30885632291641 ()
  • 20885632291644 ()
  • 10885632291647 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Glove Exam Nitrile Ice Blue 3.5g Medium Powder Free Textured Finger 100Ea/Bx 10Bx/Ca Non-Sterile Not Made with Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
GLV2702
In Commercial Distribution

  • 30885632291634 ()
  • 20885632291637 ()
  • 10885632291630 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Glove Exam Nitrile Ice Blue 3.5g Small Powder Free Textured Finger 100Ea/Bx 10Bx/Ca Non-Sterile Not Made with Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
GLV2701
In Commercial Distribution

  • 30885632291627 ()
  • 20885632291620 ()
  • 10885632291623 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Glove Exam Nitrile Ice Blue 3.5g XSmall Powder Free Textured Finger 100Ea/Bx 10Bx/CA Non-Sterile Not Made with Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
GLV2700
In Commercial Distribution

  • 30885632291610 ()
  • 20885632291613 ()
  • 10885632291616 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Nasogastric Tube Fastener Adult Skin-Friendly Adhesive 6x8cm NonWoven Fabric Beige Wrap-around Tube Securement Tab CA/2000 Not made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
55569
In Commercial Distribution

  • 10885632417115 ()
  • 30885632417119 ()


  • Nasogastric tube holder, noninvasive
GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (75 Tests, 31 days)
INSTRUMENTATION LABORATORY COMPANY
00077407508
In Commercial Distribution

  • 00195226000764 ()


  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (150 Tests, 31 days)
INSTRUMENTATION LABORATORY COMPANY
00077415008
In Commercial Distribution

  • 00195226000757 ()


  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (300 Tests, 31 days)
INSTRUMENTATION LABORATORY COMPANY
00077430008
In Commercial Distribution

  • 00195226000740 ()


  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (450 Tests, 31 days)
INSTRUMENTATION LABORATORY COMPANY
00077445008
In Commercial Distribution

  • 00195226000733 ()


  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (600 Tests, 21 days)
INSTRUMENTATION LABORATORY COMPANY
00077360008
In Commercial Distribution

  • 00195226000726 ()


  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 450 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055445010
In Commercial Distribution

  • 08426950807810 ()
00055445010

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 300 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055430010
In Commercial Distribution

  • 08426950807759 ()
00055430010

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 150 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055415010
In Commercial Distribution

  • 08426950807698 ()
00055415010

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 75 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055407510
In Commercial Distribution

  • 08426950807636 ()
00055407510

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 600 Test 21 Days
INSTRUMENTATION LABORATORY COMPANY
00055360010
In Commercial Distribution

  • 08426950807599 ()
00055360010

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glu, Lac, Hct, tBili, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 75 Test 30DAY
INSTRUMENTATION LABORATORY COMPANY
00027407511
In Commercial Distribution

  • 08426950554714 ()
00027407511

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glu, Lac, Hct, tBili, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 150 Test 30DAY
INSTRUMENTATION LABORATORY COMPANY
00027415011
In Commercial Distribution

  • 08426950485728 ()
00027415011

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glu, Lac, Hct, tBili, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 450 Test 30DAY
INSTRUMENTATION LABORATORY COMPANY
00027445011
In Commercial Distribution

  • 08426950485711 ()
00027445011

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glu, Lac, Hct, tBili, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 600 Sample 21DAY
INSTRUMENTATION LABORATORY COMPANY
00027360011
In Commercial Distribution

  • 08426950485698 ()
00027360011

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glu, Lac, Hct, tBili, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 300 Test 30DAY
INSTRUMENTATION LABORATORY COMPANY
00027430011
In Commercial Distribution

  • 08426950481058 ()
00027430011

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
CA 19-9 is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB51110 ()
BSB 5111

  • Cancer antigen 19-9 (CA19-9) GI IVD, antibody
CA 19-9 is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB51100 ()
BSB 5110

  • Cancer antigen 19-9 (CA19-9) GI IVD, antibody
CA 19-9 is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.1 ml
In Commercial Distribution

  • B502BSB51090 ()
BSB 5109

  • Cancer antigen 19-9 (CA19-9) GI IVD, antibody
Foam Positioner Prone and Lateral Head White Polyurethane Foam White CA/15 PRONE AND LATERAL HEAD POSITIONING Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49483
In Commercial Distribution

  • 20885632448680 ()
  • 10885632448683 ()


  • Freestanding patient positioner, single-use
Foam Positioner Prone and Lateral Head White Polyurethane Foam White CA/20 PRONE AND LATERAL HEAD POSITIONING Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49490
In Commercial Distribution

  • 20885632448673 ()
  • 10885632448676 ()


  • Freestanding patient positioner, single-use
Foam Positioner OR Table Positioning Kits Blue White Polyurethane Foam Blue White CA/6 WITH SCP HTC Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49459
In Commercial Distribution

  • 20885632448529 ()
  • 10885632448522 ()


  • Freestanding patient positioner, single-use
Foam Positioner OR Table Positioning Kits Standard Polyurethane Foam Blue CA/6 W Arm Prot Headrst Drawsht Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49448
In Commercial Distribution

  • 20885632444712 ()
  • 10885632444715 ()


  • Freestanding patient positioner, single-use
Foam Positioner OR Table Positioning Kits XLPolyurethane Foam Blue CA/6 W XL Arm Prot Headrst Drawsht Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49446
In Commercial Distribution

  • 20885632444699 ()
  • 10885632444692 ()


  • Freestanding patient positioner, single-use
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