MediByte Electrode Prep Kit 8130-20

GUDID B1408130201

Consumables to be used with the MediByte. The single-use kit contains: Nonin Flexiwrap Probe Tape, 3.6 V 1/2 AA Lithium Battery, 8597 Oronasal cannula, Snap Electrodes and Snap Electrode Prep Pads.

Braebon Medical Corporation

Gas-sampling/monitoring respiratory tubing, single-use

• Primary Device ID: B1408130201
• NIH Device Record Key: a3ee7ff8-9f4e-4ed0-99e3-befc33371c44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MediByte Electrode Prep Kit
• Version Model Number: 8130-20
• Catalog Number: 8130-20
• Company DUNS: 251731105
• Company Name: Braebon Medical Corporation
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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: 888.462.4841
• Email: info@braebon.com
• Phone: 888.462.4841
• Email: info@braebon.com
• Phone: 888.462.4841
• Email: info@braebon.com
• Phone: 888.462.4841
• Email: info@braebon.com
• Phone: 888.462.4841
• Email: info@braebon.com
• Phone: 888.462.4841
• Email: info@braebon.com
• Phone: 888.462.4841
• Email: info@braebon.com
• Phone: 888.462.4841
• Email: info@braebon.com
• Phone: 888.462.4841
• Email: info@braebon.com
• Phone: 888.462.4841
• Email: info@braebon.com
• Phone: 888.462.4841
• Email: info@braebon.com
• Phone: 888.462.4841
• Email: info@braebon.com
• Phone: 888.462.4841
• Email: info@braebon.com
• Phone: 888.462.4841
• Email: info@braebon.com
• Phone: 888.462.4841
• Email: info@braebon.com
• Phone: 888.462.4841
• Email: info@braebon.com
• Phone: 888.462.4841
• Email: info@braebon.com
• Phone: 888.462.4841
• Email: info@braebon.com
• Phone: 888.462.4841
• Email: info@braebon.com
• Phone: 888.462.4841
• Email: info@braebon.com
• Phone: 888.462.4841
• Email: info@braebon.com
• Phone: 888.462.4841
• Email: info@braebon.com
• Phone: 888.462.4841
• Email: info@braebon.com
• Phone: 888.462.4841
• Email: info@braebon.com
• Phone: 888.462.4841
• Email: info@braebon.com
• Phone: 888.462.4841
• Email: info@braebon.com
• Phone: 888.462.4841
• Email: info@braebon.com
• Phone: 888.462.4841
• Email: info@braebon.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B14081300 [Unit of Use]
HIBCC	B1408130201 [Primary]

FDA Product Code

• IKD: Cable, Electrode

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: 2019-11-18
• Device Publish Date: 2019-11-08

On-Brand Devices [MediByte Electrode Prep Kit]

• B1408130201: Consumables to be used with the MediByte. The single-use kit contains: Nonin Flexiwrap Probe Tap
• B1408129201: Consumables to be used with the MediByte. The single-use kit contains: 3.6 V 1/2 AA Lithium Batt
• B1408128201: Consumables to be used with the MediByte. The single-use kit contains: 8597 Oronasal cannula, Sn