Provizio SEM Scanner S

Basic Information

• Brand Name: Provizio SEM Scanner S
• Primary DI: 00860740002647
• Version / Model: 02647
• Company Name: Bruin Biometrics, LLC
• Labeler DUNS: 962732025
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-28
• Public Version: 2
• Public Version Date: 2024-01-03
• Public Version Status: Update
• Public Device Record Key: 633040d7-dcc8-4fe9-87cc-77f75cd0253f

Device Description

Provizio SEM Scanner S - Disposable Sensor Head

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QEF	Pressure Ulcer Management Tool	Gastroenterology, Urology	876.2100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63424	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 bioimpedance as an indication of sub-epidermal moisture, a marker of pressure-induced tissue damage (e.g., pressure ulcer).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860740002647	GS1

Premarket Submissions

Submission Number	Supplement Number
DEN170021	000