← Back to catalogue
Vivo 1/2/3 Humidifier
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 006977Model Heated Patient Circuits
Identity
- Trade Name
- Vivo 1/2/3 Humidifier EUDAMEDVivo 1/2, Vivo 3 FDA UDI
- Generic Name
- Heated respiratory humidifier FDA UDI
- Device Name
- Heated Patient Circuits EUDAMEDAttachable Humidifier FDA UDI
- Model / Reference
- Heated Patient Circuits EUDAMED006977 EUDAMEDFDA UDI
- Description
- Attachable Humidifier FDA UDI
Identifiers
- Catalog Number
- 006977 FDA UDI
- Primary DI / UDI-DI
- 07321820069774 EUDAMEDFDA UDI
- Basic UDI-DI
- 7321820149999Q EUDAMED
- 510(k) Number
- K240779 FDA UDI
- FDA Product Code
- BTT FDA UDI
- EMDN Code
- R020107 THERMOREGULATED BREATHING CIRCUITS EUDAMED
- GMDN Term
- Heated respiratory humidifier FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5450 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Vivo 1/2/3 Humidifier by Breas Medical AB — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240778 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 7321820149999Q | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Breas Medical AB
- EUDAMED SRN
- SE-MF-000001061
Sources (3)
- EUDAMED 63133e8b-60de-40c3-a72e-9449a9709196 61 fields · synced Oct 6, 2026
- FDA UDI f108f0d9-1477-4460-a8e4-7a3feca3ac67 36 fields · synced May 30, 2026
- FDA 510(k) K240778 1 fields · synced May 18, 2026