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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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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
Foam Positioner OR Table Positioning Kits XL Polyurethane Foam Blue CA/6 W Arm Prot Headrst Drawsht Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49444
In Commercial Distribution

  • 20885632444675 ()
  • 10885632444678 ()


  • Freestanding patient positioner, single-use
Elastic Bandage Double Length 4inx11yd 4inx11yd Cotton Tan Self Closure CA/24 Double Length Self Closure Sterile Not made with Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
REB4112
In Commercial Distribution

  • 30885632436868 ()
  • 10885632436864 ()
  • 20885632436861 ()


  • Pressure bandage, non-latex, single-use
Elastic Bandage Double Length 6inx11yd 6inx11yd Cotton Tan Self Closure CA/24 Double Length Self Closure Sterile Not made with Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
REB6112
In Commercial Distribution

  • 30885632436851 ()
  • 10885632436857 ()
  • 20885632436854 ()


  • Pressure bandage, non-latex, single-use
Replacement Pad for Hill-Rom 941 CA Stretcher: 5"T Standard Foam with 4-Way Stretch Conductive Covering. 27"W x 78"L x 5"T
Coulmed Products Group LLC
THR06
In Commercial Distribution

  • 10810087352285 ()
THR06

  • Stretcher mattress
REMStar Auto, BlueTooth, Canada
Respironics, Inc.
REMStar Auto, with BlueTooth, CA
In Commercial Distribution

  • 00606959030541 ()
561CABT

  • Home CPAP unit
REMstar Pro, with BlueTooth, Canada
Respironics, Inc.
REMstar Pro w/BlueTooth, CA
In Commercial Distribution

  • 00606959030169 ()
461CABT

  • Home CPAP unit
DreamStation BiPAP AVAPS 30, Canada
Respironics, Inc.
DreamStation BiPAP AVAPS30 AAM, CA
In Commercial Distribution

  • 00606959040908 ()
CAX1130S12

  • Portable electric ventilator
PRI Cellular Modem, Australia, Canada
Respironics, Inc.
PRI Cellular Modem, AU, CA
In Commercial Distribution

  • 00606959040403 ()
100215C

  • Clinical laboratory information system
Dorma 200 with Humidifier, Canada
Respironics, Inc.
Dorma 200 with Humidifier, CA
In Commercial Distribution

  • 00606959038585 ()
CAV201H

  • Home CPAP unit
  • Heated respiratory humidifier
REMstar Plus, System One 60 Series, Canada
Respironics, Inc.
REMstar Plus, 60 Series, CA
In Commercial Distribution

  • 00606959030053 ()
CA261S

  • Home CPAP unit
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