Inogen Rove 4 IO-401
GUDID 00817131020414
The Inogen Rove 4™ Portable Oxygen Concentrator system is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Inogen Rove 4™ Oxygen Concentrator may be used in a home, institution, vehicles and various mobile environments.
INOGEN, INC.
Mobile/portable oxygen concentrator| Primary Device ID | 00817131020414 |
| NIH Device Record Key | 7eb7263e-4300-47b7-a880-1dddc53a1349 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Inogen Rove 4 |
| Version Model Number | 10-10417-00-01 (BT) |
| Catalog Number | IO-401 |
| 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 | true |
| 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 | 2146362670 |
| quality@inogen.net | |
| Phone | 2146362670 |
| quality@inogen.net | |
| Phone | 2146362670 |
| quality@inogen.net | |
| Phone | 2146362670 |
| quality@inogen.net | |
| Phone | 2146362670 |
| quality@inogen.net | |
| Phone | 2146362670 |
| quality@inogen.net | |
| Phone | 2146362670 |
| quality@inogen.net | |
| Phone | 2146362670 |
| quality@inogen.net | |
| Phone | 2146362670 |
| quality@inogen.net | |
| Phone | 2146362670 |
| quality@inogen.net | |
| Phone | 2146362670 |
| quality@inogen.net | |
| Phone | 2146362670 |
| quality@inogen.net | |
| Phone | 2146362670 |
| quality@inogen.net | |
| Phone | 2146362670 |
| quality@inogen.net | |
| Phone | 2146362670 |
| quality@inogen.net | |
| Phone | 2146362670 |
| quality@inogen.net | |
| Phone | 2146362670 |
| quality@inogen.net | |
| Phone | 2146362670 |
| quality@inogen.net | |
| Phone | 2146362670 |
| quality@inogen.net | |
| Phone | 2146362670 |
| quality@inogen.net | |
| Phone | 2146362670 |
| quality@inogen.net | |
| Phone | 2146362670 |
| quality@inogen.net | |
| Phone | 2146362670 |
| quality@inogen.net | |
| Phone | 2146362670 |
| quality@inogen.net | |
| Phone | 2146362670 |
| quality@inogen.net | |
| Phone | 2146362670 |
| quality@inogen.net | |
| Phone | 2146362670 |
| quality@inogen.net | |
| Phone | 2146362670 |
| quality@inogen.net | |
| Phone | 2146362670 |
| quality@inogen.net | |
| Phone | 2146362670 |
| quality@inogen.net | |
| Phone | 2146362670 |
| quality@inogen.net | |
| Phone | 2146362670 |
| quality@inogen.net | |
| Phone | 2146362670 |
| quality@inogen.net |
Operating and Storage Conditions
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817131020414 [Primary] |
FDA Product Code
| CAW | Generator, Oxygen, Portable |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-01 |
| Device Publish Date | 2024-10-24 |
Devices Manufactured by INOGEN, INC.
| 00817131020414 - Inogen Rove 4 | 2024-11-01The Inogen Rove 4™ Portable Oxygen Concentrator system is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Inogen Rove 4™ Oxygen Concentrator may be used in a home, institution, vehicles and various mobile environments. |
| 00817131020414 - Inogen Rove 4 | 2024-11-01 The Inogen Rove 4™ Portable Oxygen Concentrator system is used on a prescriptive basis by patients requiring supplemental oxyg |
| 00817131020513 - Inogen Rove 6 | 2024-11-01 2.1. The Inogen Rove 6™ Portable Oxygen Concentrator system is used on a prescriptive basis by patients requiring supplemental |
| 00817131020223 - TAV 7ft O2 Delivery Tubing | 2020-03-30 TAV 7ft O2 Delivery Tubing, 10-09889-XX-01 |
| 00817131020230 - TAV 25ft O2 Delivery Tubing | 2020-03-30 TAV 25ft O2 Delivery Tubing, 10-09890-XX-01 |
| 00817131020247 - TAV 50ft O2 Delivery Tubing | 2020-03-30 TAV 50ft O2 Delivery Tubing, 10-09891-XX-01 |
| 00817131020308 - TAV Nasal Interface | 2020-03-30 TAV Nasal Interface (10-09815-XX-01) |
| 00817131020377 - Nasal Interface, 1PK | 2020-03-30 Nasal Interface, 1PK, RP-1009 |
| 00817131020384 - 7ft O2 Delivery Tube TAV, 1PK | 2020-03-30 7ft O2 Delivery Tube TAV, 1PK, RP-1010 |
Trademark Results [Inogen Rove 4]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INOGEN ROVE 4 97678905 not registered Live/Pending |
Inogen, Inc. 2022-11-15 |
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