VU

GUDID 00860009142916

The VU System provides real-time images of the contact pressure profile under a patient in a bed-care setting. This feedback helps caregivers to successfully offload pressure, which substantially reduces the risk of pressure injuries. This product version is designed for use on bariatric beds / patients.

Wellsense, Inc.

Body-surface pressure mapping system

• Primary Device ID: 00860009142916
• NIH Device Record Key: 9d82bba6-2960-49a4-875b-a580d8303f64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VU
• Version Model Number: WS-MAT-200-04
• Company DUNS: 080403189
• Company Name: Wellsense, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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: false
• 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	00860009142916 [Primary]

FDA Product Code

• JFC: System, Pressure Measurement, Intermittent

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-07
• Device Publish Date: 2022-11-29

On-Brand Devices [VU]

• 00860009142916: The VU System provides real-time images of the contact pressure profile under a patient in a bed
• 00860009142909: The VU System provides real-time images of the contact pressure profile under a patient in a bed
• 00860009142923: The VU system provides real-time images of the contact pressure profile under a patient in a bed