FDA.reportPublic FDA data

NewLife Elite

Primary DI
M638AS0051U0
Brand
NewLife Elite
Company
AIRSEP CORPORATION
Model
AS005-1U
Device description
Oxygen Concentrator, 1-5 LPM, base model, 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
M638AS0051U0PrimaryHIBCC0

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
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
M638AS09410NewLife IntensityAS094-12015-06-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885304034834DeVilbissDEVILBISS HEALTHCARE LLCCAW2026-05-12
00885304034841DeVilbissDEVILBISS HEALTHCARE LLCCAW2026-05-12
00885304034858DeVilbissDEVILBISS HEALTHCARE LLCCAW2026-05-12
00860007698262MOSTPacific Consolidated Industries LLCCAW2026-05-06
06934726614316LongfianLongfian Scitech Co., Ltd.CAW2026-05-04
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
06933257948488YUWELL Portable Oxygen ConcentratorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.CAW2026-02-24
00810178884452ViveBreatheVIVE HEALTH LLCCAW2026-01-30
00850018761451Internal Battery PM Upgrade USB DriveVentec Life Systems, Inc.CAW2025-12-02
06953077101160Oxygen concentratorShenyang Canta Medical Tech.Co.,LtdCAW2025-10-08
06953077101177Oxygen concentratorShenyang Canta Medical Tech.Co.,LtdCAW2025-10-08
M766AS200SW460AryaCAIRE INC.CAW2025-08-13
00850018761413Internal Battery PM Upgrade USB DriveVentec Life Systems, Inc.CAW2025-08-06
06933257921856YUWELL Oxygen ConcentratorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.CAW2024-01-09
10840330700396ProcureTwin Med, LLCCAW2022-11-03
M766AS200SW6AryaCAIRE INC.CAW2022-05-26
00855573007761VOCSNVentec Life Systems, Inc.CAW2022-04-12
00709078014062InLine Water TrapWESTMED, INC.CAW2022-03-31
00850018761178VOCSN Power SupplyVentec Life Systems, Inc.CAW2022-03-23
00850018761130VOCSNVentec Life Systems, Inc.CAW2021-03-03