| Primary Device ID | 00817131020179 |
| NIH Device Record Key | 3b692a43-f134-4343-96b3-408ea038b813 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Inogen One G4 Oxygen Concentrator - Bluetooth |
| Version Model Number | 630 Bluetooth |
| Catalog Number | IO-400 |
| 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 |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 36642240000232 - TUB10 | 2025-03-20 1 single patient use expiratory kit, composed of 1 tube, 1 filter programmed to allow 10 therapy sessions and 10 disposable mout |
| 36642240000928 - SIMEOX 200 | 2025-03-20 Simeox 200 airway clearance device with installed battery, remote control, power supply, transport bag and user manual |
| 36642240001604 - SIMEOX | 2025-03-20 Simeox_H airway clearance device, with remote control, power supply, transport bag and user manual |
| 36642240001772 - TUB25 | 2025-03-20 1 single patient use expiratory kit, composed of 1 tube, 1 filter programmed to allow 25 therapy sessions and 3 reusable mouthpi |
| 36642240001840 - SIMEOX 200 | 2025-03-20 Simeox 200 airway clearance device, with remote control, power supply, transport bag and user manual.
3664224SIMEOX+KIT8F |
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| 00817131020223 - TAV 7ft O2 Delivery Tubing | 2020-03-30 TAV 7ft O2 Delivery Tubing, 10-09889-XX-01 |