Provizio SEM250

GUDID 00860740002661

Provizio SEM Scanner OEM Parts Kit

Bruin Biometrics, LLC

Localized oedema electrical impedance scanner Localized oedema electrical impedance scanner Localized oedema electrical impedance scanner Localized oedema electrical impedance scanner Localized oedema electrical impedance scanner Localized oedema electrical impedance scanner Localized oedema electrical impedance scanner Localized oedema electrical impedance scanner Localized oedema electrical impedance scanner Localized oedema electrical impedance scanner Localized oedema electrical impedance scanner Localized oedema electrical impedance scanner Localized oedema electrical impedance scanner Localized oedema electrical impedance scanner Localized oedema electrical impedance scanner Localized oedema electrical impedance scanner Localized oedema electrical impedance scanner Localized oedema electrical impedance scanner Localized oedema electrical impedance scanner Localized oedema electrical impedance scanner Localized oedema electrical impedance scanner Localized oedema electrical impedance scanner

• Primary Device ID: 00860740002661
• NIH Device Record Key: ff1a8bdb-2871-4ae0-ab3d-8cfd07322f20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Provizio SEM250
• Version Model Number: 02661
• 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: false
• 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	00860740002661 [Primary]

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: 2022-07-06 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: 2022-07-06Provizio SEM Scanner OEM Parts Kit
• 00860740002661 - Provizio SEM250: 2022-07-06 Provizio SEM Scanner OEM Parts Kit