FDA UDI
In Commercial Distribution
🇺🇸 United States
YUWELL Sleep Apnea Breathing Therapy Mask
DI: 06922166513061
·
Model: YN-03 Cushion (XL)
·
Suzhou Yuyue Medical Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- YUWELL Sleep Apnea Breathing Therapy Mask
- Primary DI
- 06922166513061
- Version / Model
- YN-03 Cushion (XL)
- Company Name
- Suzhou Yuyue Medical Technology Co., Ltd.
- Labeler DUNS
- 421307196
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-26
- Public Version
- 1
- Public Version Date
- 2025-10-06
- Public Version Status
- New
- Public Device Record Key
- 5b2e8ba1-6c46-4562-9953-181324583641
Device Description
YN-03 Nasal Mask Parts, Cushion (Extra large)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | 868.5905 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57815 | CPAP/BPAP nasal mask, reusable | A flexible, form-shaped device designed to be placed over a user's nose to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic and/or silicone materials that create an airtight seal around the nose. It is available in various designs and sizes and stabilized with a headstrap. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 26922166513065 | GS1 | 50 | In Commercial Distribution | ||
| Primary | 06922166513061 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K203347 | 000 |