Identity
- Trade Name
- Curaplex FDA UDI
- Generic Name
- Non-rebreathing oxygen face mask FDA UDI
- Device Name
- Adult Procedural Oxygen Mask - Medium Concentration FDA UDI
- Model / Reference
- 301-0318LTEZ FDA UDI
- Description
- Adult Procedural Oxygen Mask - Medium Concentration FDA UDI
Identifiers
- Catalog Number
- 301-0318LTEZ FDA UDI
- Primary DI / UDI-DI
- 00812574026009 FDA UDI
- FDA Product Code
- BYG FDA UDI
- GMDN Term
- Non-rebreathing oxygen face mask FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5580 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Curaplex by Tri-Anim Health Services, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Tri-Anim Health Services, Inc.
Sources (1)
- FDA UDI 23f18eae-8197-4464-a4ac-08966d1b385c 35 fields · synced May 30, 2026