FDA.reportPublic FDA data

NewLife Intensity 10

Primary DI
M638AS099101U0
Brand
NewLife Intensity 10
Company
AIRSEP CORPORATION
Model
AS099-101U
Device description
Oxygen Concentrator, 1-10 LPM, Single flow, with Oxygen Monitor, Re-manufactured.
Published
2015-06-15
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M638AS099101U0PrimaryHIBCC0

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
834499415
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M638AS07440Airsep Corp.CentroxAS074-42025-02-28
M638AS07710FreeStyle 5AS077-12015-06-15
M638AS0771CU0FreeStyle 5AS077-1CU2015-06-15
M638AS0771U0FREESTYLE 5AS077-1U2015-07-27
M638AS07810FocusAS078-12015-06-15
M638AS0781CU0FocusAS078-1CU2015-06-15
M638AS0781U0FocusAS078-1U2015-07-27
M638AS09510FreeStyleAS095-12015-06-15
M638AS0951CU0FreeStyleAS095-1CU2015-06-15
M638AS0951U0FreeStyleAS095-1U2015-07-28
M638AS00510NewLife EliteAS005-12015-06-15
M638AS005100NewLife EliteAS005-102015-06-15
M638AS0051U0NewLife EliteAS005-1U2015-06-15
M638AS00540NewLife EliteAS005-42015-06-15
M638AS0054U0NewLife EliteAS005-4U2015-06-15
M638AS00570NewLife EliteAS005-72015-06-15
M638AS005810NewLife EliteAS005-812015-06-15
M638AS005840NewLife EliteAS005-842015-06-15
M638AS005870NewLife EliteAS005-872015-06-15
M638AS005900NewLife EliteAS005-902015-06-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10840330700396ProcureTwin Med, LLCCAW2022-11-03
M766AS200SW6AryaCAIRE INC.CAW2022-05-26
00840117310254Resp-O2 Oxygen Concentrator, 5LDynarex CorporationCAW2022-05-10
00709078014062InLine Water TrapWESTMED, INC.CAW2022-03-31
00850018761178VOCSN Power SupplyVentec Life Systems, Inc.CAW2022-03-23
00850018761130VOCSNVentec Life Systems, Inc.CAW2021-03-03
00850018761048VOCSN Patient Breathing PackageVentec Life Systems, Inc.CAW2020-10-07
00850018761062VOCSN Patient Breathing PackageVentec Life Systems, Inc.CAW2020-10-07
10807141000114MOVES SLCThornhill Research IncCAW2020-10-01
10807141000121MOVES SLCThornhill Research IncCAW2020-10-01
M766AS200SW30FreeStyle Comfort CAIRE INC.CAW2020-08-06
00885304032502DeVilbissDEVILBISS HEALTHCARE LLCCAW2020-05-27