OxyGo NEXT Oxygen Concentrator - Bluetooth 1400-3000u

GUDID 00817131020186

OxyGo NEXT Oxygen Concentrator - Bluetooth (10-08630-XX-XX)

INOGEN, INC.

Portable oxygen concentrator

• Primary Device ID: 00817131020186
• NIH Device Record Key: 94455a65-1bba-475c-9b58-cebf68004f6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OxyGo NEXT Oxygen Concentrator - Bluetooth
• Version Model Number: 1260 Bluetooth
• Catalog Number: 1400-3000u
• 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

• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817131020186 [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: 2019-05-06
• Device Publish Date: 2019-04-26

Devices Manufactured by INOGEN, INC.

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• 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