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VIvo 50/55/60/65 T-piece with plug
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 005120Model Patient circuitsModel Patient circuits (Non-heated)
Identity
- Trade Name
- VIvo 50/55/60/65 T-piece with plug EUDAMEDT-piece with plug EUDAMEDVivo Series FDA UDI
- Generic Name
- Ventilator breathing circuit, reusable FDA UDI
- Device Name
- T-piece with plug EUDAMEDFDA UDIPatient circuits (Non-heated) EUDAMED
- Model / Reference
- Patient circuits EUDAMED005120 EUDAMEDFDA UDIPatient circuits (Non-heated) EUDAMED
- Description
- T-piece with plug FDA UDI
Identifiers
- Catalog Number
- 005120 FDA UDI
- Primary DI / UDI-DI
- 07321820051205 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07321820051205 EUDAMED7321820109998U EUDAMED
- FDA Product Code
- BZO FDA UDI
- EMDN Code
- R02010199 STANDARD BREATHING CIRCUITS - OTHER EUDAMED
- GMDN Term
- Ventilator breathing circuit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5975 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
VIvo 50/55/60/65 T-piece with plug by Breas Medical AB — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-07321820051205 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-07321820051205 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Breas Medical AB
- EUDAMED SRN
- SE-MF-000001061
Sources (3)
- EUDAMED 851ae657-d714-4fd1-8c2d-c5b08cef8edb 61 fields · synced Oct 5, 2026
- EUDAMED 9b8ada3f-051d-4c54-8184-32dee8a7b7c8 61 fields · synced May 18, 2026
- FDA UDI 06925946-329a-4640-be11-50c63519b33a 35 fields · synced May 30, 2026