FDA.reportPublic FDA data

Oxygen Concentrator

Primary DI
06955623000019
Brand
Oxygen Concentrator
Company
SYSMED (CHINA) CO.,LTD
Model
M50
Published
2020-11-25
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
06955623000019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06955623000019069556230000196955623000019

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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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
06955623000033Oxygen ConcentratorMQ502020-12-09

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Primary DI, Brand, Company table
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00810178885770ViveBreatheVIVE HEALTH LLCCAW2026-04-26
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15060031380191RUGGED OXYGEN GENERATOR (ROG)MOLECULAR PRODUCTS LIMITEDCAW2026-04-21
06933257948488YUWELL Portable Oxygen ConcentratorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.CAW2026-02-24
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