Identity
- Trade Name
- Wellleaad Oxygen Mask EUDAMEDOxygen Mask FDA UDI
- Generic Name
- Rebreathing oxygen face mask FDA UDI
- Device Name
- Oxygen Mask EUDAMEDOxygen Mask Pediatric standard FDA UDI
- Model / Reference
- R01A01031F EUDAMEDFDA UDIOxygen Mask EUDAMED
- Description
- Oxygen Mask Pediatric standard FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944932765962 EUDAMEDFDA UDI
- Basic UDI-DI
- 69449327FR01A01JV EUDAMED
- FDA Product Code
- BYG FDA UDI
- EMDN Code
- R03010201 AIR/OXYGEN MASKS EUDAMED
- GMDN Term
- Rebreathing oxygen face mask FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5580 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Rebreathing oxygen face mask
Oxygen Mask by Well Lead Medical Co., Ltd — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Rebreathing oxygen face mask.
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- Oro-Nasal Mask — HANS RUDOLPH, INC. · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Well Lead Medical Co., Ltd
Sources (2)
- FDA UDI cb994fca-c2c2-4768-a244-508d44fe6040 33 fields · synced Jun 18, 2026
- EUDAMED a7cefdc2-12f7-45e4-8545-27e7abd962f4 61 fields · synced Jun 18, 2026