Oxlife Independence POC

GUDID 00869694000112

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.

O2 CONCEPTS, LLC

Portable oxygen concentrator
Primary Device ID00869694000112
NIH Device Record Keybaa5c6bd-1a98-4c2f-ab88-a872d9ec177f
Commercial Distribution StatusIn Commercial Distribution
Brand NameOxlife Independence POC
Version Model Number301-0001CE
Company DUNS034756852
Company NameO2 CONCEPTS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone877-867-4008
Emailinfo@o2-concepts.com

Operating and Storage Conditions

Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100869694000112 [Primary]

FDA Product Code

CAWGenerator, Oxygen, Portable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-18
Device Publish Date2017-07-13

On-Brand Devices [Oxlife Independence POC]

00869694000112The O2 Concepts Oxlife Independence is indicated on a prescription basis for the administration
00869694000105The O2 Concepts Oxlife Independence is indicated on a prescription basis for the administration

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