Brevio

GUDID B1870223

Neuro-sensor, 5 pouches/box

NEUROTRON MEDICAL, INC.

Diagnostic peripheral nerve electrical stimulation system

• Primary Device ID: B1870223
• NIH Device Record Key: a0e54f0c-f1ec-4c3d-aca6-7d0ef24c58c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Brevio
• Version Model Number: BRV-0250
• Company DUNS: 147018519
• Company Name: NEUROTRON MEDICAL, INC.
• Device Count: 5
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B1870220 [Unit of Use]
HIBCC	B1870223 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012069

FDA Product Code

• JXE: Device, Nerve Conduction Velocity Measurement

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-30

Devices Manufactured by NEUROTRON MEDICAL, INC.

• B1870800 - TheraMist: 2024-12-12 Electrolyte solution, 4 oz. spray bottle
• B1870810 - PDC Restorer: 2024-12-12 Conductive foot pad, 4 in. x 13 in., 2/package
• B1870820 - PDC Restorer: 2024-12-12 Conductive amputee duo-sleeve, dual polarity, 1/package
• B1870830 - PDC Restorer: 2024-12-12 Conductive pad, 2 in. x 16 in., 2/package
• B1870470 - PDC Restorer: 2024-10-22 Conductive pad, 1.5 in. x 8 in., 2/package
• B1870790 - PDC Restorer: 2024-10-22 Conductive pad, 2 in. x 3 in., 2/package
• B1870780 - PDC Restorer: 2023-11-13 Conductive pad, 3 in. x 5 in., 2/package
• B1870770 - PDC Restorer: 2023-07-28 Conductive duo-knee, dual polarity, 1/package