Inogen

Primary DI
06933257935419
Brand
Inogen
Company
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
Model
Voxi 5
Device description
This oxygen concentrator is intended for using as an oxygen supplement device in the professional healthcare facility andhome healthcare environment. It provides high concentration of oxygen to persons requiring oxygen therapy. This device is to beused as an oxygen supplement and is NOT considered life-supporting or life-sustaining.
Published
2025-06-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K213825000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213825000Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5AJiangsu Yuyue Medical Equipment & Supply Co., Ltd.2023-04-28CAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06933257935419PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06933257935419069332579354196933257935419

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
528704000
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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06933257931244YUWELL® Infrared Ear ThermometerYHT108YHT1080022026-05-07
06933257931251YUWELL® Infrared Ear ThermometerYHT202YHT2020022026-05-07
06933257931268YUWELL® Infrared Ear ThermometerYHT208YHT2080022026-05-07
06933257922006YUWELL® Finger Pulse OximeterYX1102026-05-06
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06933257923188YUWELL® Finger Pulse OximeterYX1062026-05-06
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06933257916593YUWELL Electronic Blood Pressure MonitorYE660F2025-06-12
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06933257914124YUWELL Electronic Blood Pressure MonitorYE620B2025-06-09

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