VU

GUDID 00860009142923

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 variant for narrow format hospital beds.

Wellsense, Inc.

Body-surface pressure mapping system

• Primary Device ID: 00860009142923
• NIH Device Record Key: 29dfae5c-a771-4767-9f8d-ecd55b4394e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VU
• Version Model Number: WS-MAT-200-06
• 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	00860009142923 [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: 2024-04-17
• Device Publish Date: 2024-04-09

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