Identity
- Trade Name
- Vivo 50 FDA UDI
- Generic Name
- Portable electric ventilator FDA UDI
- Device Name
- Continuous, Ventilator, Home Use FDA UDI
- Model / Reference
- US FDA UDI
- Description
- Continuous, Ventilator, Home Use FDA UDI
Identifiers
- Catalog Number
- 215116 FDA UDI
- Primary DI / UDI-DI
- 07321822151163 FDA UDI
- 510(k) Number
- K123144 FDA UDI
- FDA Product Code
- NOU FDA UDI
- GMDN Term
- Portable electric ventilator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Vivo 50 by Breas Medical AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K123144 also covers:
- Vivo 50 — BREAS MEDICAL, INC.
- Vivo 50 — BREAS MEDICAL, INC.
- Vivo 50 — Breas Medical AB
- Vivo 50 — Breas Medical AB
- Vivo 50 — Breas Medical AB
- Vivo 50 — Breas Medical AB
- Vivo 50 — Breas Medical AB
- Vivo 50 — Breas Medical AB
- Vivo 50 — Breas Medical AB
- Vivo 50 — Breas Medical AB
- Vivo 50 — Breas Medical AB
- Vivo 50 — Breas Medical AB
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Breas Medical AB
Sources (1)
- FDA UDI 31ae50e3-8bcd-4df6-b9f1-bfdf6b7eb33c 37 fields · synced May 29, 2026