Provizio SEM Scanner

GUDID 00860740002616

Provizio SEM Scanner - Integrated Sensor Head

Bruin Biometrics, LLC

Localized oedema electrical impedance scanner
Primary Device ID00860740002616
NIH Device Record Keya2e58f37-6549-418e-bc5a-e79332640f53
Commercial Distribution StatusIn Commercial Distribution
Brand NameProvizio SEM Scanner
Version Model Number02616
Company DUNS962732025
Company NameBruin Biometrics, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860740002616 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QEFPressure Ulcer Management Tool

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-06
Device Publish Date2022-06-28

Devices Manufactured by Bruin Biometrics, LLC

00860740002616 - Provizio SEM Scanner2022-07-06Provizio SEM Scanner - Integrated Sensor Head
00860740002616 - Provizio SEM Scanner2022-07-06 Provizio SEM Scanner - Integrated Sensor Head
00860740002623 - Provizio SEM Scanner S2022-07-06 Provizio SEM Scanner S - Disposable Sensor - Manual PTID
10860740002637 - Provizio SEM Scanner S Sensor2022-07-06 Provizio SEM Scanner S Sensor - Individual
00860740002647 - Provizio SEM Scanner S2022-07-06 Provizio SEM Scanner S - Disposable Sensor Head
00860740002654 - Provizio SEM Scanner Gateway2022-07-06 Provizio SEM Scanner Gateway USB
00860740002661 - Provizio SEM2502022-07-06 Provizio SEM Scanner OEM Parts Kit

Trademark Results [Provizio SEM Scanner]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PROVIZIO SEM SCANNER
PROVIZIO SEM SCANNER
88323322 not registered Live/Pending
Bruin Biometrics, LLC
2019-03-03

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