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Vivo 3
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 229000Model Vivo 3510(k) K240779
Identity
- Trade Name
- Vivo 3 EUDAMEDFDA UDI
- Generic Name
- Portable electric ventilator FDA UDI
- Device Name
- Vivo 3 EUDAMEDVentilator, Continuous, Minimal Ventilatory Support, Facility Use FDA UDI
- Model / Reference
- Vivo 3 EUDAMEDFDA UDI229000 EUDAMED
- Description
- Ventilator, Continuous, Minimal Ventilatory Support, Facility Use FDA UDI
Identifiers
- Catalog Number
- 229500 FDA UDI
- Primary DI / UDI-DI
- 07321822290008 EUDAMEDFDA UDI
- Basic UDI-DI
- 732182229999BY EUDAMED
- 510(k) Number
- K240779 FDA UDI
- FDA Product Code
- MNT FDA UDIBTT FDA UDI
- EMDN Code
- Z12030103 PULMONARY VENTILATORS FOR NON–HOSPITAL USE EUDAMED
- GMDN Term
- Portable electric ventilator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5895 FDA UDI868.5450 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Vivo 3 by Breas Medical AB — Class IIb — 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 | K240779 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 732182229999BY | Class IIb | Active |
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Manufacturer
- Manufacturer
- Breas Medical AB
- EUDAMED SRN
- SE-MF-000001061
Sources (3)
- EUDAMED c5e3a322-bf5a-47f5-8d6e-1d2ee96c31eb 85 fields · synced Jun 18, 2026
- FDA UDI 800f7e4e-df88-43db-8037-cbf6629b1b5c 36 fields · synced May 30, 2026
- FDA 510(k) K240779 1 fields · synced May 18, 2026