Identity
- Trade Name
- Curaplex FDA UDI
- Generic Name
- Capnography oxygen mask FDA UDI
- Device Name
- Adult Procedural Oxygen Mask - Medium Concentration & CO2 Monitoring (Male to Male) FDA UDI
- Model / Reference
- 301-0318LTEZ-MM FDA UDI
- Description
- Adult Procedural Oxygen Mask - Medium Concentration & CO2 Monitoring (Male to Male) FDA UDI
Identifiers
- Catalog Number
- 301-0318LTEZ-MM FDA UDI
- Primary DI / UDI-DI
- 00818834026055 FDA UDI
- FDA Product Code
- BYG FDA UDI
- GMDN Term
- Capnography oxygen 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 dce39dd6-1e64-4f8e-b243-14ac3830ca3b 35 fields · synced Jun 1, 2026