Identity
- Trade Name
- Vivo 45 LS FDA UDI
- Generic Name
- Portable electric ventilator FDA UDI
- Device Name
- Air Bypass, Vivo 45 LS FDA UDI
- Model / Reference
- 007064 FDA UDI
- Description
- Air Bypass, Vivo 45 LS FDA UDI
Identifiers
- Catalog Number
- 007064 FDA UDI
- Primary DI / UDI-DI
- 07321820070640 FDA UDI
- 510(k) Number
- K193586 FDA UDI
- FDA Product Code
- CBK FDA UDINOU FDA UDI
- GMDN Term
- Portable electric ventilator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Portable electric ventilator
Vivo 45 LS by Breas Medical AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K193586 also covers:
- Vivo 45 LS — BREAS MEDICAL, INC.
- Vivo 45 LS — BREAS MEDICAL, INC.
- Vivo 45 LS — BREAS MEDICAL, INC.
- Vivo 45 LS — BREAS MEDICAL, INC.
- Vivo 45 LS, Vivo 65 — BREAS MEDICAL, INC.
- Vivo 45 LS, Vivo 65 — BREAS MEDICAL, INC.
- Vivo 45 LS — Breas Medical AB
- Vivo 45 LS — Breas Medical AB
- Vivo 45 LS — Breas Medical AB
- Vivo 45 LS — Breas Medical AB
- Vivo 45 LS — Breas Medical AB
- Vivo 45 LS — 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 040dbaf8-baab-4896-97f7-e9d29a3e7a90 36 fields · synced May 30, 2026