O2 CONCEPTS, LLC

FDA Device Registration & Listing · Middlebury, CT, US · Registration 3008910673

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008910673
FEI Number
3008910673
Entity Name
O2 CONCEPTS, LLC
City/State/Country
Middlebury, CT, US
Establishment Address
199 Park Road Ext Ste B, Middlebury, CT 06762, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
O2 Concepts, LLC (Owner Number: 10035280)
Owner / Operator Contact Address
199 Park Rd Ext, Suite B, Middlebury, CT 06762, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K182454
PMA Number
N/A

All Registered Proprietary Names

Oxlife Independence Oxlife Liberty Oxlife Freedom

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CAW Generator, Oxygen, Portable Anesthesiology Class 2 868.5440 2019-02-13

Official Correspondent

Michelle Bruen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

O2 Concepts, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K003939 Invacare Corp. VENTURE HOME FILL II, MODEL IOH 200 2001-03-21
K942357 Healthdyne, Inc. H-500 ALLIANCE OXYGEN CONCENTRATOR 1994-05-27
K042262 Sequal Technologies, Inc. INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10 2004-09-10
K003472 Sequal Technologies, Inc. INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM 2001-06-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0038-2007 Sunrise Medical 2
DeVilbiss iFill Personal Oxygen Station model number 535D.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008910673. Last updated year: 2026. Please use registration number 3008910673 when referencing this establishment in official correspondence.
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