Identity
- Trade Name
- O-Two FDA UDI
- Generic Name
- Rebreathing oxygen face mask FDA UDI
- Device Name
- The Single-use Adult Medium Concentration Mask with Tubing is used to provide respiratory therapy. It is achieved by connecting the device to an oxygen gas supply. The adult patient can inhale various concentration of oxygen through the mask. FDA UDI
- Model / Reference
- 02RT1041 FDA UDI
- Description
- The Single-use Adult Medium Concentration Mask with Tubing is used to provide respiratory therapy. It is achieved by connecting the device to an oxygen gas supply. The adult patient can inhale various concentration of oxygen through the mask. FDA UDI
Identifiers
- Catalog Number
- 02RT1041-CS FDA UDI
- Primary DI / UDI-DI
- 07540195070219 FDA UDI
- FDA Product Code
- BYG FDA UDI
- GMDN Term
- Rebreathing 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
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
No
FDA UDI
Category: Rebreathing oxygen face mask
O-Two by O-Two Medical Technologies Inc — 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
- Venticaire Lite — FLEXICARE MEDICAL LIMITED · Class I
- 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
- O-Two Medical Technologies Inc
Sources (1)
- FDA UDI 5fbdce13-9287-4d6b-8549-2711ab825a10 36 fields · synced Jun 6, 2026