Inogen One G5 Oxygen Concentrator - Bluetooth IO-500

GUDID 00817131020162

Inogen One G5 Oxygen Concentrator - Bluetooth (10-08123-XX-XX)

INOGEN, INC.

Portable oxygen concentrator

• Primary Device ID: 00817131020162
• NIH Device Record Key: 6df78248-63ee-4d26-9e58-158e640c901a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inogen One G5 Oxygen Concentrator - Bluetooth
• Version Model Number: 1260 Bluetooth
• Catalog Number: IO-500
• 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: 8055620500
• Email: compliance@inogen.net

Operating and Storage Conditions

• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817131020162 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-10
• Device Publish Date: 2019-04-02

Devices Manufactured by INOGEN, INC.

• 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
• 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