Aerogen Solo Nebulizer System

GUDID 05391517935011

Aerogen Solo Nebulizer Kit US

AEROGEN LIMITED

Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated
Primary Device ID05391517935011
NIH Device Record Key3cec268a-5b80-4083-92b8-9d5f945ad1b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameAerogen Solo Nebulizer System
Version Model NumberAG-AS5000-PH-US
Company DUNS989510003
Company NameAEROGEN LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+35391540400
Emailinfo@aerogen.com
Phone+35391540400
Emailinfo@aerogen.com
Phone+35391540400
Emailinfo@aerogen.com
Phone+35391540400
Emailinfo@aerogen.com
Phone+35391540400
Emailinfo@aerogen.com
Phone+35391540400
Emailinfo@aerogen.com
Phone+35391540400
Emailinfo@aerogen.com
Phone+35391540400
Emailinfo@aerogen.com
Phone+35391540400
Emailinfo@aerogen.com
Phone+35391540400
Emailinfo@aerogen.com
Phone+35391540400
Emailinfo@aerogen.com
Phone+35391540400
Emailinfo@aerogen.com
Phone+35391540400
Emailinfo@aerogen.com
Phone+35391540400
Emailinfo@aerogen.com
Phone+35391540400
Emailinfo@aerogen.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 450 millibar and 1100 millibar
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 450 millibar and 1100 millibar
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 450 millibar and 1100 millibar
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 450 millibar and 1100 millibar
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 450 millibar and 1100 millibar
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 450 millibar and 1100 millibar
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 450 millibar and 1100 millibar
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 450 millibar and 1100 millibar
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 450 millibar and 1100 millibar
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 450 millibar and 1100 millibar
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 450 millibar and 1100 millibar
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 450 millibar and 1100 millibar
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 450 millibar and 1100 millibar
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 450 millibar and 1100 millibar
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 450 millibar and 1100 millibar
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS105391517935011 [Primary]
GS105391517935011 [Primary]
GS105391517935011 [Primary]
GS105391517935011 [Primary]
GS105391517935011 [Primary]
GS105391517935011 [Primary]
GS105391517935011 [Primary]
GS105391517935011 [Primary]
GS105391517935011 [Primary]
GS105391517935011 [Primary]
GS105391517935011 [Primary]
GS105391517935011 [Primary]
GS105391517935011 [Primary]
GS105391517935011 [Primary]
GS105391517935011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAFNebulizer (Direct Patient Interface)
CAFNebulizer (Direct Patient Interface)
CAFNebulizer (Direct Patient Interface)
CAFNebulizer (Direct Patient Interface)
CAFNebulizer (Direct Patient Interface)
CAFNebulizer (Direct Patient Interface)
CAFNebulizer (Direct Patient Interface)
CAFNebulizer (Direct Patient Interface)
CAFNebulizer (Direct Patient Interface)
CAFNebulizer (Direct Patient Interface)
CAFNebulizer (Direct Patient Interface)
CAFNebulizer (Direct Patient Interface)
CAFNebulizer (Direct Patient Interface)
CAFNebulizer (Direct Patient Interface)
CAFNebulizer (Direct Patient Interface)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-17
Device Publish Date2020-06-09

Devices Manufactured by AEROGEN LIMITED

05391517935011 - Aerogen Solo Nebulizer System2020-06-17Aerogen Solo Nebulizer Kit US
05391517935011 - Aerogen Solo Nebulizer System2020-06-17 Aerogen Solo Nebulizer Kit US
05391517935035 - Aerogen® USB Controller System2020-03-17 Aerogen Solo USB Controller Starter Kit
05391517934021 - Aerogen® Solo Nebulizer System2019-06-13 T-Piece Ped/Neo (PC)
05391517933321 - Aerogen® Solo; Aerogen Ultra2018-10-25 Oxygen Tubing 2m
05391517930016 - Aerogen® Professional Nebulizer System2018-09-24 Aerogen Pro Nebulizer System
05391517930030 - Aerogen® Professional Nebulizer System2018-09-24 Pro Adult T-Piece 22mm
05391517930047 - Aerogen® Professional Nebulizer System2018-09-24 Pro Pediatric T-Piece 15mm
05391517930061 - Aerogen® Professional Nebulizer System2018-09-24 Pro Pediatric Adapter Kit

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