Devices

Aeroneb Professional Nebulizer System

  • Modèle / numéro de série
    FRIWO AC/DC Adapter Model Number: GPP10;   The FRIWO AC/DC Adapter is supplied with the following Aeroneb Nebulizer systems and their respective model numbers:   1) Model Number: AG-AS3000-AU; Lot Numbers: 9144140519057 , 9144140616062 , 9144140702155 , 9144140710034;  2) Model Number: AG-AS3000-IN; Lot Numbers: 9125140522116 , 9125140526101 , 9125140527077 , 9125140609002 , 9125140609007 , 9125140616064 , 9125140627057 , 9125140702166 , 9125140710031 , 9125140805010 , 9125140805134;  3) Model Number: AG-AS3000-NE; Lot Numbers: 9122140520089 , 9122140521089 , 9122140528119 , 9122140609041 , 9122140626100 , 9122140728097 , 9122140730088;  4) Model Number: AG-AS3000-SC; Lot Numbers: 9124140609011 , 9124140620092 , 9124140623091;  5) Model Number: AG-AS3000-SE; Lot Numbers: 9123140521074 , 9123140610023 , 9123140710033 , 9123140724097;  6) Model Number: AG-AS3000-UK; Lot Numbers: 9120140519028 , 9120140519061 , 9120140526111 , 9120140630135 , 9120140701144 , 9120140702156 , 9120140714044;  7) Model Number: AG-AS3000-US; Lot Numbers: 9121140521090 , 9121140522091 , 9121140522093 , 9121140523094 , 9121140613066 , 9121140630138 , 9121140707023 , 9121140709030;  8) Model Number: AG-PX1000-IN; Lot Numbers: 9133140704002;  9) Model Number: ; Lot Numbers: ;  10) Model Number: AG-PX1000-NE; Lot Numbers: 9130140528119 , 9130140616060 , 9130140730040;  11) Model Number: AG-PX1000-SC; Lot Numbers: 9132140519072 , 9132140526107;  12) Model Number: AG-PX1000-SE; Lot Numbers: 9131140623154;  13) Model Number: AG-PX1000-UK; Lot Numbers: 9128140519081 , 9128140630135 , 9128140709024;  14) Model Number: AG-PX1000-US; Lot Numbers: 9129140527093 , 9129140617070 , 9129140714047 , 9129140721087;  15) Model Number: AG-PX1000-US-Promo; Lot Numbers: 9129140522090 , 9129140522091 , 9129140527093 , 9129140528095 , 9129140528096 , 9129140616066 , 9129140617067 , 9129140617069 , 9129140617070 , 9129140617071
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of CA, GA, IL, MS, NC, and TX, and the countries of Australia, Belgium, Canada, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hungary, India, Ireland, Israel, Italy, Kuwait, Libya, Malaysia, Netherlands, Norway, Poland, Qatar, Russia, South Korea, Singapore, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.
  • Description du dispositif
    The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. || The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. || The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.
  • Manufacturer
    Aerogen Ltd.
  • 1 Event

Fabricant

Aerogen Ltd.
  • Adresse du fabricant
    Aerogen Ltd., Galway Business Park, Dangan, Galway Ireland
  • Société-mère du fabricant (2017)
    Aerogen Ltd.
  • Source
    USFDA

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Aeroneb Professional Nebulizer System
  • Modèle / numéro de série
    FRIWO AC/DC Adapter Model Number: GPP10;   The FRIWO AC/DC Adapter is supplied with the following Aeroneb Nebulizer Pro family of systems: and their respective model numbers:   1) Model Number: AG-AP1040-AU; Lot Numbers: 8003140519057 , 8003140708015 , 8003140722089 ;  2) Model Number: AG-AP1040-EU; Lot Numbers: 800140731124 , 8000140520074 , 8000140520087 , 8000140520087 , 8000140530103 , 8000140619082 , 8000140620092 , 8000140624103 , 8000140624118 , 8000140701104 , 8000140702153 , 8000140721056 , 8000140726097 , 8000140728100 , 8000140728117 , 8000140728120 , 8000140625100,  8000140624100;  3) Model Number: AG-AP1040-UK; Lot Numbers: 8001140519067 , 8001140624115 , 8001140714044 , 8001140728065 , 8001140731125;  4) Model Number: AG-AP1040-US; Lot Numbers: 8002140520090 , 8002140521088 , 8002140522091 , 8002140522093 , 8002140523094 , 8002140523095 , 8002140526114 , 8002140527096 , 8002140603121 , 8002140603130 , 8002140613067 , 8002140613068 , 8002140616069 , 8002140616070 , 8002140626123 , 8002140627124 , 8002140627125 , 8002140627138 , 8002140711036 , 8002140714042 , 8002140721085 , 8002140721087 , 8002140722091 , 8002140722092 , 8002140722093;  5) Model Number: AG-AP1500-IN; Lot Numbers: 9948140702153;  6) Model Number: AG-AP1500-UK; Lot Numbers: 9953140801132;  7) Model Number: AG-AP1500-US; Lot Numbers: 9939140522091 , 9939140630138;  8) Model Number: AG-AP6000(DG)-FR; Lot Numbers: 9998140611025;  9) Model Number: AG-AP6000(DG)-GE; Lot Numbers: 9997140611024;  10) Model Number: AG-AP6000(DG)-IN; Lot Numbers: 9996140728059;  11) Model Number: AG-AP6000-AU; Lot Numbers: 9915140722056 , 9915140722089;  12) Model Number: AG-AP6000-CH; Lot Numbers: 9966140521021 , 9966140624102;  13) Model Number: AG-AP6000-FR; Lot Numbers: 9905140521074 , 9905140526108 , 9905140610023 , 9905140731072;  14) Model Number: AG-AP6000-GE; Lot Numbers: 9904140519141 , 9904140520089 , 9904140626100 , 9904140702149 , 9904140726097;  15) Model Number: AG-AP6000-IN; Lot Numbers: 9913140520026 , 9913140526077 , 9913140526102 , 9913140603083 , 9913140609009 , 9913140617074 , 9913140624117 , 9913140703160 , 9913140703160 , 9913140703164 , 9913140704022 , 9913140709028 , 9913140709029 , 9913140711152 , 9913140721008 , 9913140721057 , 9913140721078 , 9913140728104 , 9913140728111 , 9913140801129 , 9913140805137 , 9913140604097,  9913140603097 , 9913140609129,  9913140603129,  9913140724004,  9913140725004,  9913140729004,  9913140728004,  9913140723004;  16) Model Number: AG-AP6000-IT; Lot Numbers: 9906140515023 , 9906140710033;  17) Model Number: AG-AP6000-NO; Lot Numbers: 9916140519058;  18) Model Number: AG-AP6000-RU; Lot Numbers: 9968140704166,  9968140721077;  19) Model Number: AG-AP6000-SP; Lot Numbers: 9907140519028 , 9907140730097;  20) Model Number: AG-AP6000-SW; Lot Numbers: 9927140607011;  21) Model Number: AG-AP6000-UK; Lot Numbers: 9903140520025 , 9903140526111 , 9903140722056 , 9903140728098;  22) Model Number: AG-AP6000-US; Lot Numbers: 9902140616065 , 9902140616067 , 9902140617070
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of CA, GA, IL, MS, NC, and TX, and the countries of Australia, Belgium, Canada, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hungary, India, Ireland, Israel, Italy, Kuwait, Libya, Malaysia, Netherlands, Norway, Poland, Qatar, Russia, South Korea, Singapore, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.
  • Description du dispositif
    The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. || The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. || The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.
  • Manufacturer
    Aerogen Ltd.
Aeroneb Professional Nebulizer System
  • Modèle / numéro de série
    FRIWO AC/DC Adapter Model Number: GPP10;   The FRIWO AC/DC Adapter is supplied with the following Aeroneb Nebulizer systems and their respective model numbers:   1) Model Number: 1079422; Lot Numbers: 9070140620088 , 9070140723088 , 9070140723088;  2) Model Number: 1082693; Lot Numbers: 9073140618134;  3) Model Number: 1082694; Lot Numbers: 9074140530079
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of CA, GA, IL, MS, NC, and TX, and the countries of Australia, Belgium, Canada, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hungary, India, Ireland, Israel, Italy, Kuwait, Libya, Malaysia, Netherlands, Norway, Poland, Qatar, Russia, South Korea, Singapore, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.
  • Description du dispositif
    The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. || The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. || The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.
  • Manufacturer
    Aerogen Ltd.
Aeroneb Professional Nebulizer System
  • Modèle / numéro de série
    FRIWO AC/DC Adapter Model Number: GPP10;   The FRIWO AC/DC Adapter is supplied with the following Aeroneb Nebulizer systems and their respective model numbers:   1) Model Number: AG-UC1000-NE; Lot Numbers: 9263140718116 , 9263140718137 , 9263140730049;  2) Model Number: AG-UC1000-UK; Lot Numbers: 9235140718022 , 9235140718093 , 9235140718154;  3) Model Number: AG-UC1500-NE; Lot Numbers: 9264140627057 , 9264140627100 , 9264140721112 , 9264140724100;  4) Model Number: AG-UC1500-SC; Lot Numbers: 9277140721040;  5) Model Number: AG-UC1500-SE; Lot Numbers: 9276140731046
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of CA, GA, IL, MS, NC, and TX, and the countries of Australia, Belgium, Canada, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hungary, India, Ireland, Israel, Italy, Kuwait, Libya, Malaysia, Netherlands, Norway, Poland, Qatar, Russia, South Korea, Singapore, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.
  • Description du dispositif
    The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. || The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. || The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.
  • Manufacturer
    Aerogen Ltd.