E-ST

GUDID 00815871020404

Avante

General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system

• Primary Device ID: 00815871020404
• NIH Device Record Key: 0cc03e8f-a1d2-43e5-afeb-a7a98f96dfb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E-ST
• Version Model Number: 60133-8
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815871020404 [Primary]

FDA Product Code

• HEP: Monitor, Blood-Flow, Ultrasonic

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 [E-ST]

• 00815871020428: 60132PRO2
• 00815871020411: 60132PRO
• 00815871020404: 60133-8
• 00815871020398: 60133
• 00815871020381: 601324
• 00815871020374: 601323
• 00815871020367: 60132