YUWELL Portable Oxygen Concentrator

GUDID 06933257924925

The Portable Oxygen Concentrator, model: Spirit-3, is intended to provide supplemental oxygen in a home, institutional, or travel environment. And the device is used with adult only, not used with pediatrics, infant, or neonate patients, etc.

JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.

Mobile/portable oxygen concentrator
Primary Device ID06933257924925
NIH Device Record Key55e95205-0ecf-4872-b81b-02cf1d00deee
Commercial Distribution StatusIn Commercial Distribution
Brand NameYUWELL Portable Oxygen Concentrator
Version Model NumberSpirit-3
Company DUNS528704000
Company NameJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106933257924925 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAWGenerator, Oxygen, Portable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-18
Device Publish Date2025-06-10

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