OxyGo IO-300
GUDID 00817131020100
OxyGo (Inogen One G3 Oxygen Concentrator) (10-06327-XX-XX) (1400-1000)
INOGEN, INC.
Portable oxygen concentrator| Primary Device ID | 00817131020100 |
| NIH Device Record Key | c7befb87-0fbe-4c71-a28b-c9cd6bb592b4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OxyGo |
| Version Model Number | 1050 |
| Catalog Number | IO-300 |
| Company DUNS | 136729634 |
| Company Name | INOGEN, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 805-562-0500 |
| compliance@inogen.net | |
| Phone | 805-562-0500 |
| compliance@inogen.net | |
| Phone | 805-562-0500 |
| compliance@inogen.net | |
| Phone | 805-562-0500 |
| compliance@inogen.net | |
| Phone | 805-562-0500 |
| compliance@inogen.net | |
| Phone | 805-562-0500 |
| compliance@inogen.net | |
| Phone | 805-562-0500 |
| compliance@inogen.net | |
| Phone | 805-562-0500 |
| compliance@inogen.net | |
| Phone | 805-562-0500 |
| compliance@inogen.net | |
| Phone | 805-562-0500 |
| compliance@inogen.net | |
| Phone | 805-562-0500 |
| compliance@inogen.net | |
| Phone | 805-562-0500 |
| compliance@inogen.net | |
| Phone | 805-562-0500 |
| compliance@inogen.net | |
| Phone | 805-562-0500 |
| compliance@inogen.net | |
| Phone | 805-562-0500 |
| compliance@inogen.net | |
| Phone | 805-562-0500 |
| compliance@inogen.net | |
| Phone | 805-562-0500 |
| compliance@inogen.net | |
| Phone | 805-562-0500 |
| compliance@inogen.net | |
| Phone | 805-562-0500 |
| compliance@inogen.net | |
| Phone | 805-562-0500 |
| compliance@inogen.net |
Operating and Storage Conditions
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817131020100 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K032818
FDA Product Code
| CAW | Generator, Oxygen, Portable |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-03-27 |
On-Brand Devices [OxyGo]
| 00817131020100 | OxyGo (Inogen One G3 Oxygen Concentrator) (10-06327-XX-XX) (1400-1000) |
| 00817131020094 | OxyGo (Inogen One G3 Oxygen Concentrator) (10-06327-XX-XX) (1400-1000) |
| 00817131020087 | OxyGo (Inogen One G3 Oxygen Concentrator) (10-05560-XX-XX) (1400-1000) |
| 00817131020070 | OxyGo (Inogen One G3 Oxygen Concentrator) (10-05560-XX-XX) (1400-1000) |
Trademark Results [OxyGo]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OXYGO 86438602 5124820 Live/Registered |
OXYGO HQ FLORIDA LLC 2014-10-29 |
 OXYGO 79339464 not registered Live/Pending |
SEQUENT AG (SEQUENT SA) (SEQUENT Ltd.) 2022-02-22 |
 OXYGO 74318981 1789985 Dead/Cancelled |
DANISCO US INC. 1992-10-01 |
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