Oxlife Freedom POC

GUDID 00869694000129

The O2 Concepts Oxlife Freedom is indicated on a prescription basis for the administration of supplemental oxygen. It is not intended for life support, nor does it provide any patient monitoring capabilities.

O2 CONCEPTS, LLC

Portable oxygen concentrator

• Primary Device ID: 00869694000129
• NIH Device Record Key: a9ea79ac-7783-4a6f-9e42-35c2ee5b8a8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oxlife Freedom POC
• Version Model Number: 301-0003V
• Company DUNS: 034756852
• Company Name: O2 CONCEPTS, LLC
• 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: 877-867-4008
• Email: info@o2-concepts.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869694000129 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182454

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: 2019-04-23
• Device Publish Date: 2019-04-15

Devices Manufactured by O2 CONCEPTS, LLC

• 00869694000136 - Oxlife Liberty POC: 2023-03-10 The O2 Concepts Oxlife Liberty is indicated on a prescription basis for the administration of supplemental oxygen. It is not int
• 00869694000129 - Oxlife Freedom POC: 2019-04-23The O2 Concepts Oxlife Freedom is indicated on a prescription basis for the administration of supplemental oxygen. It is not intended for life support, nor does it provide any patient monitoring capabilities.
• 00869694000129 - Oxlife Freedom POC: 2019-04-23 The O2 Concepts Oxlife Freedom is indicated on a prescription basis for the administration of supplemental oxygen. It is not int
• 00869694000105 - Oxlife Independence POC: 2019-02-18 The O2 Concepts Oxlife Independence is indicated on a prescription basis for the administration of supplemental oxygen. It is n
• 00869694000112 - Oxlife Independence POC: 2019-02-18 The O2 Concepts Oxlife Independence is indicated on a prescription basis for the administration of supplemental oxygen. It is no