BRAEBON 3-Foot Double Loop Effort Belt 0523-3

GUDID B140052330

Belt for use with PVDF Respiratory effort sensor..

Braebon Medical Corporation

Pneumograph

• Primary Device ID: B140052330
• NIH Device Record Key: 469b6730-0ef4-480a-91ce-be78a71f7d32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BRAEBON 3-Foot Double Loop Effort Belt
• Version Model Number: 0523-3
• Catalog Number: 0523-3
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• Length: 1 Feet
• Length: 1 Feet

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B140052330 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982216

FDA Product Code

• BZQ: Monitor, Breathing Frequency

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: 2016-09-22

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