Identity
- Trade Name
- VU FDA UDI
- Generic Name
- Body-surface pressure mapping system FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- WS-MAT-200-04 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860009142916 FDA UDI
- FDA Product Code
- JFC FDA UDI
- GMDN Term
- Body-surface pressure mapping system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.1600 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Body-surface pressure mapping system
Vu by Wellsense, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Wellsense, Inc.
Sources (1)
- FDA UDI 9d82bba6-2960-49a4-875b-a580d8303f64 33 fields · synced May 31, 2026