YUWELL Portable Oxygen Concentrator

Primary DI
06933257948488
Brand
YUWELL Portable Oxygen Concentrator
Company
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
Model
SP-3
Device description
The Portable Oxygen Concentrator, model: SP-3, is intended to provide supplemental oxygen in a home, institutional, or travelenvironment. And the device is used with adult only, not used with pediatrics, infant, or neonate patients, etc.
Published
2026-02-24
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
K242736000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242736000Portable Oxygen Concentrator (Spirit-3)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.2025-06-05CAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06933257948488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06933257948488069332579484886933257948488

GMDN Terms#

Term, Definition table
TermDefinition
Mobile/portable oxygen concentratorA mobile/portable 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 used in a home, institution, or a vehicle and typically has internal batteries for transportable use.

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
Primary DIBrandModelCatalogPublished
06933257929432YUWELL® Infrared Ear ThermometerYHT108YHT1080012026-05-07
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06933257931213YUWELL® Infrared Ear ThermometerYHT202YHT2020012026-05-07
06933257931244YUWELL® Infrared Ear ThermometerYHT108YHT1080022026-05-07
06933257931251YUWELL® Infrared Ear ThermometerYHT202YHT2020022026-05-07
06933257931268YUWELL® Infrared Ear ThermometerYHT208YHT2080022026-05-07
06933257922006YUWELL® Finger Pulse OximeterYX1102026-05-06
06933257922013YUWELL® Finger Pulse OximeterYX3102026-05-06
06933257923171YUWELL® Finger Pulse OximeterYX1052026-05-06
06933257923188YUWELL® Finger Pulse OximeterYX1062026-05-06
06933257923133YUWELL® Infrared Ear ThermometerYHT1002025-09-05
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06933257921948YUWELL®Finger Pulse OximeterYX1022025-06-16
06933257921955YUWELL® Finger Pulse OximeterYX1032025-06-16
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06933257921634YUWELL Electronic Blood Pressure MonitorYE8800AR2025-06-12
06933257935419InogenVoxi 52025-06-11
06933257924925YUWELL Portable Oxygen ConcentratorSpirit-32025-06-10
06933257914124YUWELL Electronic Blood Pressure MonitorYE620B2025-06-09

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