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Oxygen Mask
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref R01A02038F Model Non-Rebreath Mask with oxygen tubing
Identity
- Trade Name
- Wellleaad Oxygen Mask EUDAMEDOxygen Mask FDA UDI
- Generic Name
- Rebreathing oxygen face mask FDA UDI
- Device Name
- Oxygen Mask EUDAMEDOxygen Mask with oxygen tubing 3.05m(10ft) Pediatric standard FDA UDI
- Model / Reference
- R01A02038F EUDAMEDFDA UDINon-Rebreath Mask with oxygen tubing EUDAMED
- Description
- Oxygen Mask with oxygen tubing 3.05m(10ft) Pediatric standard FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936881166945 EUDAMEDFDA UDI
- Basic UDI-DI
- 69449327FR01A00JT 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.
- DUAL MASK-ADULT MALE NOSE CLIP MC WITH CO2 MONIT 7FT (USA) — FLEXICARE MEDICAL LIMITED · Class II
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- Ventlab — Ventlab Corp. · Class I
- Mask — Beijing Rongrui-Century Science & Technology Co. , Ltd. · Class IIa
- AMARA MASK WITH RS FRAME AND HEADGEAR LARGE, INTL — Respironics Inc. · Class IIa
- ClasStar, GanzGesMask, NIV, AAV, L — Drägerwerk AG & Co. KGaA · Class IIa
- Venticaire Lite — FLEXICARE MEDICAL LIMITED · Class I
- 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 0ba7a8c7-1380-4d10-97b0-c7f52177ddfc 33 fields · synced Jun 19, 2026
- EUDAMED bea002df-1fdd-49a3-a310-b8c0a990d75c 61 fields · synced Jun 19, 2026