Smart Trace Electrodes .080 in 1015662

GUDID B0361015662

Smart Trace Electrodes .080 in., 20 Pairs

CIRCADIANCE, LLC

Neonatal electrocardiographic electrode

• Primary Device ID: B0361015662
• NIH Device Record Key: 0a344b14-2ab7-4438-8a88-2fefdb2e214a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smart Trace Electrodes .080 in
• Version Model Number: 1015662
• Catalog Number: 1015662
• Company DUNS: 012721295
• Company Name: CIRCADIANCE, 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: 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-825-9640
• Email: info@circadiance.com
• Phone: 1-888-825-9640
• Email: info@circadiance.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B0361015662 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000206

FDA Product Code

• DRX: Electrode, Electrocardiograph

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: 2016-10-24

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