Velocity Pro

GUDID 00815871021395

Avante

Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel

• Primary Device ID: 00815871021395
• NIH Device Record Key: 34279aa3-8dc3-4afb-88d8-a63070722308
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Velocity Pro
• Version Model Number: 60134P15
• Company DUNS: 178440426
• Company Name: Avante
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 502-244-4444
• Email: devicehelp@dremed.com
• Phone: 502-244-4444
• Email: devicehelp@dremed.com
• Phone: 502-244-4444
• Email: devicehelp@dremed.com
• Phone: 502-244-4444
• Email: devicehelp@dremed.com
• Phone: 502-244-4444
• Email: devicehelp@dremed.com
• Phone: 502-244-4444
• Email: devicehelp@dremed.com
• Phone: 502-244-4444
• Email: devicehelp@dremed.com
• Phone: 502-244-4444
• Email: devicehelp@dremed.com
• Phone: 502-244-4444
• Email: devicehelp@dremed.com
• Phone: 502-244-4444
• Email: devicehelp@dremed.com
• Phone: 502-244-4444
• Email: devicehelp@dremed.com
• Phone: 502-244-4444
• Email: devicehelp@dremed.com
• Phone: 502-244-4444
• Email: devicehelp@dremed.com
• Phone: 502-244-4444
• Email: devicehelp@dremed.com
• Phone: 502-244-4444
• Email: devicehelp@dremed.com
• Phone: 502-244-4444
• Email: devicehelp@dremed.com
• Phone: 502-244-4444
• Email: devicehelp@dremed.com
• Phone: 502-244-4444
• Email: devicehelp@dremed.com
• Phone: 502-244-4444
• Email: devicehelp@dremed.com
• Phone: 502-244-4444
• Email: devicehelp@dremed.com
• Phone: 502-244-4444
• Email: devicehelp@dremed.com
• Phone: 502-244-4444
• Email: devicehelp@dremed.com
• Phone: 502-244-4444
• Email: devicehelp@dremed.com
• Phone: 502-244-4444
• Email: devicehelp@dremed.com
• Phone: 502-244-4444
• Email: devicehelp@dremed.com
• Phone: 502-244-4444
• Email: devicehelp@dremed.com
• Phone: 502-244-4444
• Email: devicehelp@dremed.com
• Phone: 502-244-4444
• Email: devicehelp@dremed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815871021395 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152427

FDA Product Code

• DPS: 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: 4
• Public Version Date: 2019-06-19
• Device Publish Date: 2016-09-23

On-Brand Devices [Velocity Pro]

• 00815871021395: 60134P15
• 00815871021388: 60134P12
• 00815871021371: 60134P10