FDA product code QEF

Pressure Ulcer Management Tool

Gastroenterology, Urology·Class 1·21 CFR 876.2100
US regulatory classifications
US Product Code (FDA)
QEF
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US Risk Class (FDA)
Class 1
US Regulation (CFR)
21 CFR 876.2100
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Medical specialty
Gastroenterology, Urology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

A pressure ulcer management tool is a prescription device intended for patients at risk of developing pressure ulcers. The device provides output that supports a user’s decision to increase intervention. The device is an adjunct tool for pressure ulcer management that is not intended for detection or diagnostic purposes.

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About this record

Pressure Ulcer Management Tool is a medical device type in the Gastroenterology, Urology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.