Identity
- Trade Name
- Visensia FDA UDI
- Generic Name
- Medical equipment clinical data interfacing software FDA UDI
- Device Name
- Visensia® software is a computerized analysis software program designed as an adjunct to standard patient monitors or medical information systems. It operates by forming an aggregate score of patient status based on five vital signs; heart rate; respiratory rate; temperature; noninvasive blood pressure and arterial oxygen saturation. The aggregate score, the Visensia® Index, is displayed on a scale of 0-5, with 0 representing the normal end of the scale and 5 representing extreme physiological deterioration. An audible and visual alert is provided when the Visensia® index exceeds a threshold value for a period of time. The Visensia® Index is calculated whenever new data is received. FDA UDI
- Model / Reference
- 3 FDA UDI
- Description
- Visensia® software is a computerized analysis software program designed as an adjunct to standard patient monitors or medical information systems. It operates by forming an aggregate score of patient status based on five vital signs; heart rate; respiratory rate; temperature; noninvasive blood pressure and arterial oxygen saturation. The aggregate score, the Visensia® Index, is displayed on a scale of 0-5, with 0 representing the normal end of the scale and 5 representing extreme physiological deterioration. An audible and visual alert is provided when the Visensia® index exceeds a threshold value for a period of time. The Visensia® Index is calculated whenever new data is received. FDA UDI
Identifiers
- Catalog Number
- 011-0124 FDA UDI
- Primary DI / UDI-DI
- 05060457930010 FDA UDI
- 510(k) Number
- K110953 FDA UDI
- FDA Product Code
- MHX FDA UDI
- GMDN Term
- Medical equipment clinical data interfacing software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1025 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Medical equipment clinical data interfacing software
Visensia by Obs Medical — 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
- EncoreAnywhere — Respironics, Inc. · Class II
- 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
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Obs Medical
Sources (1)
- FDA UDI 4c8e347f-9dae-473e-a64b-500cd0e0ebeb 35 fields · synced May 30, 2026