Provizio SEM Scanner S Sensor

GUDID 10860740002637

Provizio SEM Scanner S Sensor - Individual

Bruin Biometrics, LLC

Localized oedema electrical impedance scanner

• Primary Device ID: 10860740002637
• NIH Device Record Key: ff439cbf-1aea-4703-98b9-f328c20e1337
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Provizio SEM Scanner S Sensor
• Version Model Number: 02630
• Company DUNS: 962732025
• Company Name: Bruin Biometrics, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860740002630 [Primary]
GS1	10860740002637 [Package]; Contains: 00860740002630; Package: Inner Pack [100 Units]; In Commercial Distribution
GS1	20860740002634 [Package]; Package: Case [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN170021

FDA Product Code

• QEF: Pressure Ulcer Management Tool

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-06
• Device Publish Date: 2022-06-28

Devices Manufactured by Bruin Biometrics, LLC

• 00860740002616 - Provizio SEM Scanner: 2022-07-06 Provizio SEM Scanner - Integrated Sensor Head
• 00860740002623 - Provizio SEM Scanner S: 2022-07-06 Provizio SEM Scanner S - Disposable Sensor - Manual PTID
• 10860740002637 - Provizio SEM Scanner S Sensor: 2022-07-06Provizio SEM Scanner S Sensor - Individual
• 10860740002637 - Provizio SEM Scanner S Sensor: 2022-07-06 Provizio SEM Scanner S Sensor - Individual
• 00860740002647 - Provizio SEM Scanner S: 2022-07-06 Provizio SEM Scanner S - Disposable Sensor Head
• 00860740002654 - Provizio SEM Scanner Gateway: 2022-07-06 Provizio SEM Scanner Gateway USB
• 00860740002661 - Provizio SEM250: 2022-07-06 Provizio SEM Scanner OEM Parts Kit