Identity
- Trade Name
- Adult Oxygen Mask High Concentration FDA UDI
- Generic Name
- Rebreathing oxygen face mask FDA UDI
- Device Name
- High Concentration, 7ft. Saflo Tube - multi-fit on one end FDA UDI
- Model / Reference
- R-2450SM FDA UDI
- Description
- High Concentration, 7ft. Saflo Tube - multi-fit on one end FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00628725096926 FDA UDI
- FDA Product Code
- KGB FDA UDI
- GMDN Term
- Rebreathing oxygen face mask FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5570 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Rebreathing oxygen face mask
Adult Oxygen Mask High Concentration by Canadian Hospital Specialties Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- ClasStar, GanzGesMask, NIV, AAV, L — Drägerwerk AG & Co. KGaA · Class IIa
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- Oro-Nasal Mask — HANS RUDOLPH, INC. · Class IIa
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 6f512a4e-bc16-4bd8-9c31-0e4459d25b95 34 fields · synced Jun 8, 2026