BRAEBON Electrode Box SE 8612

GUDID B14086120

The Electrode Box SE, which plugs into the AUX port on the MediByte®, attaches electrodes to the MediByte.

Braebon Medical Corporation

Multiple physiological signal amplifier

• Primary Device ID: B14086120
• NIH Device Record Key: 8c1e3b63-1905-4ce4-9f18-1e2aee3b39eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BRAEBON Electrode Box SE
• Version Model Number: 8612
• Catalog Number: 8612
• Company DUNS: 251731105
• Company Name: Braebon Medical Corporation
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 613.831.6690
• Email: info@braebon.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B14086120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061764

FDA Product Code

• MNR: Ventilatory Effort Recorder

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: 2019-10-28
• Device Publish Date: 2019-10-18

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