Provizio SEM Scanner

GUDID 00860740002616

Provizio SEM Scanner - Integrated Sensor Head

Bruin Biometrics, LLC

Localized oedema electrical impedance scanner

• Primary Device ID: 00860740002616
• NIH Device Record Key: a2e58f37-6549-418e-bc5a-e79332640f53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Provizio SEM Scanner
• Version Model Number: 02616
• 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: false
• Serial Number: true
• 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	00860740002616 [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: 2022-07-06Provizio SEM Scanner - Integrated Sensor Head
• 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: 2022-07-06 Provizio SEM Scanner OEM Parts Kit