FDA.reportPublic FDA data

Oxygen Concentrator

Primary DI
06955623000033
Brand
Oxygen Concentrator
Company
SYSMED (CHINA) CO.,LTD
Model
MQ50
Published
2020-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe

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
K172234000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172234000Oxygen ConcentratorSysmed (China) Co., Ltd.2018-06-01CAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06955623000033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06955623000033069556230000336955623000033

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
548237698
Device count
1
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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06955623020147Non-invasive Ventilator(Continuous Positive Airway Pressure Units, Bi-LevelAurora Bi-Level S2026-05-06
06955623020154Non-invasive Ventilator(Continuous Positive Airway Pressure Units, Bi-LevelAurora Bi-Level S/T2026-05-06
06955623020161Non-invasive Ventilator(Continuous Positive Airway Pressure Units, Bi-LevelZiZ CPAP2026-05-06
06955623020185Non-invasive Ventilator(Continuous Positive Airway Pressure Units, Bi-LevelResware BI 20 S2026-05-06
06955623020192Non-invasive Ventilator(Continuous Positive Airway Pressure Units, Bi-LevelResware BI 20 S/T2026-05-06
06955623020215Non-invasive Ventilator(Continuous Positive Airway Pressure Units, Bi-LevelResware BI 25 S2026-05-06
06955623020222Non-invasive Ventilator(Continuous Positive Airway Pressure Units, Bi-LevelResware BI 25 S/T2026-05-06
06955623000019Oxygen ConcentratorM502020-11-25

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
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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
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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
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M766AS200SW30FreeStyle Comfort CAIRE INC.CAW2020-08-06
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