Home GUDID 10860740002637 Provizio SEM Scanner S Sensor
Primary DI 10860740002637
Brand Provizio SEM Scanner S Sensor
Company Bruin Biometrics, LLC
Model 02630
Device description Provizio SEM Scanner S Sensor - Individual
Published 2022-06-28
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name QEF Pressure Ulcer Management Tool
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QEF Pressure Ulcer Management Tool Gastroenterology, Urology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10860740002637 Package GS1 100 In Commercial Distribution 20860740002634 Package GS1 2 In Commercial Distribution 00860740002630 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10860740002637 10860740002637 20860740002634 20860740002634 00860740002630 00860740002630 860740002630 0860740002630
GMDN Terms# Term, Definition table Term Definition Localized oedema electrical impedance scanner A hand-held electronic device designed to help diagnose localized oedema in subcutaneous tissue in the inflammatory phase, prior to visible skin symptoms. It is a portable noninvasive unit with a display screen and an electrode designed to scan a patient’s unbroken skin whereby low frequency electrical current is applied and detected to measure degree of tissue electrical impedance as an indication of sub-epidermal moisture, a marker of pressure-induced tissue damage (e.g., pressure ulcer).
Regulatory Flags# DUNS number 962732025 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes#