FDA UDI
In Commercial Distribution
🇺🇸 United States
YUWELL Portable Oxygen Concentrator
DI: 06933257948488
·
Model: SP-3
·
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- YUWELL Portable Oxygen Concentrator
- Primary DI
- 06933257948488
- Version / Model
- SP-3
- Company Name
- JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
- Labeler DUNS
- 528704000
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-24
- Public Version
- 1
- Public Version Date
- 2026-03-04
- Public Version Status
- New
- Public Device Record Key
- 71ca9b0c-68ba-467b-9ddf-68b887770105
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CAW | Generator, Oxygen, Portable | Anesthesiology | 868.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31321 | Mobile/portable oxygen concentrator | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06933257948488 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K242736 | 000 |