Visensia

Basic Information

• Brand Name: Visensia
• Primary DI: 05060457930010
• Version / Model: 3
• Catalog Number: 011-0124
• Company Name: OBS MEDICAL LIMITED
• Labeler DUNS: 239669802
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-04-05
• Public Version: 4
• Public Version Date: 2018-11-08
• Public Version Status: Update
• Public Device Record Key: 4c8e347f-9dae-473e-a64b-500cd0e0ebeb

Device 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	870.1025	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57967	Medical equipment clinical data interfacing software	An application software designed for transportation, calculation, aggregation and derivation of data between patient connected medical devices and external information systems used in clinical settings for automating data collection and clinical information management. It is intended to transfer waveform, infusion data, laboratory data from medical devices/lab equipment into an electronic medical record (EMR) or an application for viewing and verification by a clinician. The data can be aggregated for, e.g., patient treatment summary calculations, ordering of infusion solutions/drugs, and laboratory sample tests; it is not primarily intended to manage diagnostic/patient images.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060457930010	GS1

Premarket Submissions

Submission Number	Supplement Number
K110953	000