Identity
- Trade Name
- Heated Breathing Set EUDAMEDFDA UDI
- Generic Name
- Ventilator breathing circuit, single-use FDA UDI
- Device Name
- Bonhawa Respiratory Humidifier EUDAMEDContains: (1) Breathing Circuit (1) Water Chamber (1) Water Chamber Adaptor FDA UDI
- Model / Reference
- RHF G3-2 EUDAMEDHBCK01 EUDAMEDFDA UDI
- Description
- Contains: (1) Breathing Circuit (1) Water Chamber (1) Water Chamber Adaptor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860009312296 EUDAMEDFDA UDI
- Basic UDI-DI
- 08600093122A5X EUDAMED
- FDA Product Code
- CAI FDA UDI
- EMDN Code
- R020199 BREATHING CIRCUITS AND KITS - OTHER EUDAMED
- GMDN Term
- Ventilator breathing circuit, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5240 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
Heated Breathing Set 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 f38b6a23-9be2-4c03-b90e-f02708d82806 61 fields · synced Jun 18, 2026
- FDA UDI c6154d7e-08b1-4eaf-963f-07a4619cbbab 33 fields · synced May 30, 2026