Visensia 011-0124

GUDID 05060457930010

Visensia® software is a computerized analysis software program designed as an adjunct to standard patient monitors or medical information systems. It

OBS MEDICAL LIMITED

Medical equipment clinical data interfacing software

• Primary Device ID: 05060457930010
• NIH Device Record Key: 4c8e347f-9dae-473e-a64b-500cd0e0ebeb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visensia
• Version Model Number: 3
• Catalog Number: 011-0124
• Company DUNS: 239669802
• Company Name: OBS MEDICAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060457930010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110953

FDA Product Code

• MHX: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-08
• Device Publish Date: 2016-04-05