OxyGo IO-300

GUDID 00817131020094

OxyGo (Inogen One G3 Oxygen Concentrator) (10-06327-XX-XX) (1400-1000)

INOGEN, INC.

Portable oxygen concentrator Portable oxygen concentrator Portable oxygen concentrator
Primary Device ID00817131020094
NIH Device Record Key5f877280-6f51-4845-a703-841f50912737
Commercial Distribution StatusIn Commercial Distribution
Brand NameOxyGo
Version Model Number1050
Catalog NumberIO-300
Company DUNS136729634
Company NameINOGEN, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
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

Phone805-562-0500
Emailcompliance@inogen.net
Phone805-562-0500
Emailcompliance@inogen.net
Phone805-562-0500
Emailcompliance@inogen.net

Operating and Storage Conditions

Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -13 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100817131020094 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAWGenerator, Oxygen, Portable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-03-27

On-Brand Devices [OxyGo]

00817131020100OxyGo (Inogen One G3 Oxygen Concentrator) (10-06327-XX-XX) (1400-1000)
00817131020094OxyGo (Inogen One G3 Oxygen Concentrator) (10-06327-XX-XX) (1400-1000)
00817131020087OxyGo (Inogen One G3 Oxygen Concentrator) (10-05560-XX-XX) (1400-1000)
00817131020070OxyGo (Inogen One G3 Oxygen Concentrator) (10-05560-XX-XX) (1400-1000)

Trademark Results [OxyGo]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OXYGO
OXYGO
86438602 5124820 Live/Registered
OXYGO HQ FLORIDA LLC
2014-10-29
OXYGO
OXYGO
79339464 not registered Live/Pending
SEQUENT AG (SEQUENT SA) (SEQUENT Ltd.)
2022-02-22
OXYGO
OXYGO
74318981 1789985 Dead/Cancelled
DANISCO US INC.
1992-10-01

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