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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BiPAP Pro with BiFlex System One 60 Series BiPAP System, Canada
Respironics, Inc.
BiPAP Pro BiFlex, 60 Series, CA
In Commercial Distribution

  • 00606959031388 ()
CA661S

  • Home BPAP unit
DreamStation Auto BiPAP with Humidifier, Canada
Respironics, Inc.
DreamStation Auto BiPAP with Humidifier, CA
In Commercial Distribution

  • 00606959026650 ()
CAX700H12

  • Home BPAP unit
DreamStation BiPAP Pro with Humidifier, Canada
Respironics, Inc.
DreamStation BiPAP Pro with Humidifier, CA
In Commercial Distribution

  • 00606959026629 ()
CAX600H12

  • Home BPAP unit
DreamStation Auto CPAP with Humidifier, Canada
Respironics, Inc.
DreamStation Auto CPAP with Humidifier, CA
In Commercial Distribution

  • 00606959026599 ()
CAX500H12

  • Home CPAP unit
DreamStation Go CPAP with Bluetooth, Canada
Respironics, Inc.
DreamStation Go CPAP with Bluetooth, CA
In Commercial Distribution

  • 00606959048607 ()
CAG400S12

  • Home CPAP unit
DreamStation BiPAP AVAPS30 with Cell Modem, Canada
Respironics, Inc.
DreamStation BiPAP AVAPS30 w/Cell, CA
In Commercial Distribution

  • 00606959045705 ()
CAX1130S12C

  • Portable electric ventilator
DreamStation BiPAP AVAPS30 AAM, with WiFi, Canada
Respironics, Inc.
DreamStation BiPAP AVAPS30 w/WiFi, CA
In Commercial Distribution

  • 00606959045675 ()
CAX1130S12W

  • Portable electric ventilator
18Ga, AccuCath IV Catheter, 1.25”, Intermediate
Bard Access Systems, Inc.
AC0181252
In Commercial Distribution

  • 10801741110969 ()
  • 00801741110962 ()
  • 30801741110963 ()
  • 20801741110966 ()

  • Gauge
  • Length: 1.25 Inch
AC0181252

  • Peripheral vascular intervention infusion catheter
GEM 5000 BG ISE GL COOX TBILI 600 Test PAK 21 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glu, Lac, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2, Tbili Cartridge)
INSTRUMENTATION LABORATORY COMPANY
00055360011XC
In Commercial Distribution

  • 08426951027460 ()
00055360011XC

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM 5000 BG ISE GL COOX TBILI 300 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glu, Lac, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2, Tbili Cartridge)
INSTRUMENTATION LABORATORY COMPANY
00055430011XC
In Commercial Distribution

  • 08426951027446 ()
00055430011XC

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
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