O2 Concepts Oxlife Independence Model 301-0001
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Oxlife Independence EUDAMEDOxlife Independence POC FDA UDI
- Generic Name
- Mobile/portable oxygen concentrator FDA UDI
- Device Name
- O2 Concepts Portable Oxygen Concentrators EUDAMEDThe O2 Concepts Oxlife Independence 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. FDA UDI
- Model / Reference
- 800-0001-CE EUDAMED301-0001CE FDA UDI
- Description
- The O2 Concepts Oxlife Independence 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00869694000112 EUDAMEDFDA UDI
- Basic UDI-DI
- 08696940001O2ConceptsVR EUDAMED
- Direct Marketing DI
- 00869694000112 EUDAMED
- 510(k) Number
- K182454 FDA 510(k)
- FDA Product Code
- CAW FDA 510(k)FDA UDI
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS EUDAMED
- GMDN Term
- Mobile/portable oxygen concentrator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 868.5440 FDA 510(k)
- Regulation Number
- 868.5440 FDA 510(k)FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The Oxlife Independence Model 301-0001 is a portable oxygen generator designed to deliver medical-grade oxygen on demand. Classified as a portable oxygen generator, this device converts ambient air into concentrated oxygen for therapeutic use, particularly in settings where continuous oxygen supply is required.
This device is intended for single-use or reusable applications in clinical environments, including anesthesia and respiratory care. It is regulated under FDA 510K and MDR, with a device class of II, and operates within the scope of regulation number 868.5440. Supplied as a portable unit, it requires proper storage and handling as specified in its technical documentation to ensure functionality and safety.
Frequently asked questions
What clinical settings is the Oxlife Independence Model 301-0001 primarily intended for use in?
The Oxlife Independence Model 301-0001 is designed for clinical environments where continuous oxygen supply is required, particularly in anesthesia and respiratory care. Its portable oxygen generation capability makes it suitable for settings where traditional oxygen sources may be impractical, such as operating rooms, recovery areas, or mobile respiratory therapy units.
Is the Oxlife Independence Model 301-0001 intended for single-use or reusable applications?
The device is explicitly labeled for single-use or reusable applications in clinical settings. While it can be reused, proper cleaning, maintenance, and adherence to manufacturer guidelines are essential to ensure functionality and safety, especially in environments like anesthesia where reliability is critical.
How is the Oxlife Independence Model 301-0001 regulated, and what does that mean for buyers?
The device is regulated under FDA 510(k) clearance and the EU Medical Device Regulation (MDR), classified as a Class II medical device. This means it has undergone rigorous review by regulatory bodies to ensure safety and performance before market authorization. Buyers can expect compliance with stringent standards, though specific approvals (e.g., FDA clearance or CE marking) must be verified directly with the manufacturer or regulatory databases.
Does the Oxlife Independence Model 301-0001 come in multiple sizes or models, and if so, how do they differ?
The provided data does not specify distinct size variations or model-specific differences beyond the Model 301-0001 designation. However, the OpenFDA registration numbers (e.g., 3010440667, 3008507279) suggest multiple FEI (Final Establishment Identification) numbers, which may indicate different manufacturing lots or minor variants. For precise sizing or model distinctions, refer to the manufacturer’s technical documentation or contact O2 Concepts directly.
What storage and handling requirements should be followed to maintain the device’s functionality?
The Oxlife Independence Model 301-0001 requires proper storage and handling as outlined in its technical documentation to preserve functionality and safety. While specifics like temperature ranges or environmental conditions aren’t detailed here, reusable units must undergo maintenance per manufacturer instructions, and single-use units should be stored in a way that prevents contamination or damage. Always consult the included user manual or contact O2 Concepts for exact guidelines.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K182454 | Class II | Active |
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Manufacturer
- Manufacturer
- O2 Concepts, LLC
Sources (3)
- FDA 510(k) K182454 24 fields · synced Sep 18, 2026
- FDA UDI baa5c6bd-1a98-4c2f-ab88-a872d9ec177f 35 fields · synced May 30, 2026
- EUDAMED 359a05dd-d6d1-4d4b-890f-2ebfbfed6a5f 61 fields · synced Jul 13, 2026