FDA.reportPublic FDA data

Provizio SEM Scanner S Sensor

Primary DI
00860740002630
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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
QEFPressure Ulcer Management Tool

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QEFPressure Ulcer Management ToolGastroenterology, Urology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN170021000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN170021000SEM Scanner (Model 200)Bruin Biometrics, LLC2018-12-20QEF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860740002637PackageGS1100In Commercial Distribution
20860740002634PackageGS12In Commercial Distribution
00860740002630PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086074000263710860740002637
2086074000263420860740002634
00860740002630008607400026308607400026300860740002630

GMDN Terms#

Term, Definition table
TermDefinition
Localized oedema electrical impedance scannerA 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).

Regulatory Flags#

DUNS number
962732025
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860740002616Provizio SEM Scanner026162022-06-28
00860740002623Provizio SEM Scanner S026232022-06-28
00860740002647Provizio SEM Scanner S026472022-06-28
00860740002654Provizio SEM Scanner Gateway026542022-06-28
00860740002661Provizio SEM250026612022-06-28
10860740002637Provizio SEM Scanner S Sensor026302022-06-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860740002616Provizio SEM ScannerBruin Biometrics, LLCQEF2022-06-28
00860740002623Provizio SEM Scanner SBruin Biometrics, LLCQEF2022-06-28
10860740002637Provizio SEM Scanner S SensorBruin Biometrics, LLCQEF2022-06-28
00860740002647Provizio SEM Scanner SBruin Biometrics, LLCQEF2022-06-28
00860740002654Provizio SEM Scanner GatewayBruin Biometrics, LLCQEF2022-06-28
00860740002661Provizio SEM250Bruin Biometrics, LLCQEF2022-06-28