Identity
- Trade Name
- Vivo 50 FDA UDI
- Generic Name
- Medical equipment clinical data interfacing software FDA UDI
- Device Name
- PC Software FDA UDI
- Model / Reference
- 005928 FDA UDI
- Description
- PC Software FDA UDI
Identifiers
- Catalog Number
- 005928 FDA UDI
- Primary DI / UDI-DI
- 07321820059287 FDA UDI
- 510(k) Number
- K123144 FDA UDI
- FDA Product Code
- NOU FDA UDI
- GMDN Term
- Medical equipment clinical data interfacing software 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
Yes
FDA UDI
Category: Medical equipment clinical data interfacing software
Vivo 50 by Breas Medical AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medical equipment clinical data interfacing software.
- Atellica Connect — Siemens Healthcare Diagnostics · Class I
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- RALS — Abbott Rapid Diagnostics Informatics, Inc. · Class I
- Intesys Clinical Suite — SPACELABS HEALTHCARE (WASHINGTON), INC · Class I
- Care Orchestrator Denmark — Respironics, Inc. · Class II
- Care Orchestrator — Respironics, Inc. · Class II
- EncoreAnywhere — Respironics, Inc. · Class II
- Care Orchestrator — Respironics, Inc. · Class II
Cleared under the same submission
K123144 also covers:
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 dc91218d-2f2b-42b4-9b13-4f38c5b85561 36 fields · synced May 30, 2026