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Oxlife Liberty2 POC

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 800-0007-V

by O2 Concepts, LLC

Identity

Trade Name
Oxlife Liberty2 EUDAMED
Oxlife Liberty2 POC FDA UDI
Generic Name
Mobile/portable oxygen concentrator FDA UDI
Device Name
O2 Concepts Portable Oxygen Concentrators EUDAMED
The O2 Concepts Oxlife Liberty2 is indicated on a prescription basis for the administration of supplemental oxygen. It is notintended for life support, nor does it provide any patient monitoring capabilities. FDA UDI
Model / Reference
800-0007-V EUDAMED
301-0005VP FDA UDI
Description
The O2 Concepts Oxlife Liberty2 is indicated on a prescription basis for the administration of supplemental oxygen. It is notintended for life support, nor does it provide any patient monitoring capabilities. FDA UDI

Identifiers

Primary DI / UDI-DI
00869694000143 EUDAMEDFDA UDI
Basic UDI-DI
08696940001O2ConceptsVR EUDAMED
Direct Marketing DI
00869694000143 EUDAMED
510(k) Number
K182454 FDA UDI
FDA Product Code
CAW FDA UDI
EMDN Code
Z12159004 OXYGEN CONCENTRATORS EUDAMED
GMDN Term
Mobile/portable oxygen concentrator FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
868.5440 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Mobile/portable oxygen concentrator

Oxlife Liberty2 POC by O2 Concepts, LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Mobile/portable oxygen concentrator.

Cleared under the same submission

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
O2 Concepts, LLC

Sources (2)

  • FDA UDI a7d1318d-d9f2-4051-b8c4-0c1f29d1487e 35 fields · synced Jul 13, 2026
  • EUDAMED c289dc6f-19d1-4069-9f15-51b93daeed08 61 fields · synced Jul 13, 2026