Identity
- Trade Name
- Large Nasal Cannula EUDAMEDAdult Nasal Cannula, Large FDA UDI
- Generic Name
- Nasal oxygen cannula, basic FDA UDI
- Device Name
- Bonhawa Respiratory Humidifier EUDAMED
- Model / Reference
- RHF G3-2 EUDAMEDENC01 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860009312289 EUDAMEDFDA UDI
- Basic UDI-DI
- 08600093122A5X EUDAMED
- FDA Product Code
- CAT FDA UDI
- EMDN Code
- R0301020302 HIGH FLOW THERAPY NASAL CANNULAS (HFNC) EUDAMED
- GMDN Term
- Nasal oxygen cannula, basic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5340 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Large Nasal Cannula by Telesair, Inc — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08600093122A5X | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Telesair, Inc
- EUDAMED SRN
- US-MF-000037957
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 37747aae-8c06-4cbb-9056-48506038f8d8 61 fields · synced Jul 11, 2026
- FDA UDI bb2ac6c5-d07f-4bed-8e4f-eaab35f22071 32 fields · synced May 29, 2026