Identity
- Trade Name
- PEDIATRIC HIGH CONCENTRATION OXYGEN MASK FDA UDI
- Generic Name
- Venturi oxygen face mask FDA UDI
- Device Name
- PEDIATRIC HIGH CONCENTRATION OXYGEN MASK FDA UDI
- Model / Reference
- R-2650 FDA UDI
- Description
- PEDIATRIC HIGH CONCENTRATION OXYGEN MASK FDA UDI
Identifiers
- Catalog Number
- R-2650 FDA UDI
- Primary DI / UDI-DI
- 00628725099750 FDA UDI
- FDA Product Code
- BYG FDA UDI
- GMDN Term
- Venturi oxygen face mask FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5580 FDA UDI
- Commercial Distribution
- 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
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Venturi oxygen face mask
Pediatric High Concentration Oxygen Mask by Canadian Hospital Specialties Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Canadian Hospital Specialties Limited
Sources (1)
- FDA UDI e3cdc804-1e1c-40ed-9f81-29ff844dff11 35 fields · synced Jun 8, 2026