Provizio SEM Scanner S Sensor

GUDID 10860740002637

Provizio SEM Scanner S Sensor - Individual

Bruin Biometrics, LLC

Localized oedema electrical impedance scanner
Primary Device ID10860740002637
NIH Device Record Keyff439cbf-1aea-4703-98b9-f328c20e1337
Commercial Distribution StatusIn Commercial Distribution
Brand NameProvizio SEM Scanner S Sensor
Version Model Number02630
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 Usetrue
Lot Batchtrue
Serial Numberfalse
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
GS100860740002630 [Primary]
GS110860740002637 [Package]
Contains: 00860740002630
Package: Inner Pack [100 Units]
In Commercial Distribution
GS120860740002634 [Package]
Package: Case [2 Units]
In Commercial Distribution

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 Scanner2022-07-06 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 Sensor2022-07-06Provizio SEM Scanner S Sensor - Individual
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

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