FDA.reportPublic FDA data

Companion 5

Primary DI
M76615067013R0
Brand
Companion 5
Company
CAIRE INC.
Model
15067013R
Device description
Stationary Oxygen Concentrator, 0.5-5 LPM, Refurbished
Published
2015-07-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
CAWGenerator, Oxygen, Portable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAWGenerator, Oxygen, PortableAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121167000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121167000CAIRE COMPANION 5 OXYGEN CONCENTRATORCaire, Inc.2012-05-02CAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M76615067013R0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Stationary oxygen concentratorA stationary mains electricity (AC-powered) device designed to concentrate oxygen (O2) from ambient air and deliver the concentrated O2, typically through an attached nasal cannula, to a patient requiring oxygen therapy. It processes the air through an internal filtration system, e.g., a molecular sieve (zeolite granules or membranes), having a large total surface area to separate nitrogen (N2) from the air. It typically consists of an air compressor, filters, dual chambers, a reservoir and controls. The O2 concentration is variable depending on the flow rate utilized. It is typically wheeled but is designed to be placed in one location, e.g., an institution or a home setting.

Regulatory Flags#

DUNS number
807537683
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M766AS200SW460AryaAS200-SW462025-08-13
M766AS2001410CAIRE Inc.AS200-141AS200-1412025-08-13
M766AS2001460AryaAS200-1462025-08-13
M766AS2002410CAIRE Inc.AS200-241AS200-2412025-08-13
M766AS2002460AryaAS200-2462025-08-13
M766AS200410CAIRE Inc.AS200-41AS200-412025-08-13
M766AS200460AryaAS200-46AS200-SW412025-08-13
M766AS200SW410CAIRE Inc.AS200-SW41AS200-SW412025-08-13
M766SCE1000NANB0HOMESTYLE AspenSCE1000-NANBSCE1000-NANB2025-06-30
M766214997340IntenOxy 521499734214997342024-11-13
M766AS2006R0AryaAS200-6RAS200-6R2024-11-13
M766AS2001R0FreeStyle ComfortAS200-1RAS200-1R2024-08-09
M766AS200SW6AryaAS200-SW62022-05-26
M766AS2001060AryaAS200-1062021-11-08
M766AS2002060AryaAS200-2062021-11-08
M766AS20060AryaAS200-62021-11-08
M766AS200SW30FreeStyle Comfort AS200-SW32020-08-06
M76613256929SM0Liberator13256929SM2020-08-06
M76613256961SM0Liberator13256961SM2020-08-06
M76613256996SM0Liberator13256996SM2020-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970384252163SCIANHONSUN (NANTONG) CO.,LTDCAW2026-07-30
06975247360078HarveyMedShenzhen HarveyMed Technology Co., Ltd.CAW2026-07-30
06975247360085HarveyMedShenzhen HarveyMed Technology Co., Ltd.CAW2026-07-30
06975247360092HarveyMedShenzhen HarveyMed Technology Co., Ltd.CAW2026-07-30
16970384252160SCIANHONSUN (NANTONG) CO.,LTDCAW2026-07-30
26970384252167SCIANHONSUN (NANTONG) CO.,LTDCAW2026-07-30
06975247360061HarveyMedShenzhen HarveyMed Technology Co., Ltd.CAW2026-07-27
00841447114635Invacare® Platinum Oxygen ConcentratorINVACARE CORPORATIONCAW2026-07-21
00841447114642Invacare® Perfecto2V Oxygen ConcentratorINVACARE CORPORATIONCAW2026-07-21
00810178889624Vive BreatheVIVE HEALTH LLCCAW2026-06-01
00810178885756ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885763ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885770ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885787ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885794ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885800ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885817ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885824ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00850083102944Rhythm Healthcare, LLCRhythm Healthcare, LLCCAW2026-04-24
00850083102319Rhythm HealthcareRhythm Healthcare, LLCCAW2026-04-22
15060031380191RUGGED OXYGEN GENERATOR (ROG)MOLECULAR PRODUCTS LIMITEDCAW2026-04-21
00810178884452ViveBreatheVIVE HEALTH LLCCAW2026-01-30
00850018761451Internal Battery PM Upgrade USB DriveVentec Life Systems, Inc.CAW2025-12-02
M766AS200SW460AryaCAIRE INC.CAW2025-08-13
00850018761413Internal Battery PM Upgrade USB DriveVentec Life Systems, Inc.CAW2025-08-06
00860012953301MICITECHFoshan MIC Medical Technology Co.,Ltd.CAW2024-11-28
00860012953318MICITECHFoshan MIC Medical Technology Co.,Ltd.CAW2024-11-28
00860012953325MICITECHFoshan MIC Medical Technology Co.,Ltd.CAW2024-11-28
00860012953332MICITECHFoshan MIC Medical Technology Co.,Ltd.CAW2024-11-28
00860012953349MICITECHFoshan MIC Medical Technology Co.,Ltd.CAW2024-11-28