Compact FM

GUDID 00815871020206

Avante

Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor

• Primary Device ID: 00815871020206
• NIH Device Record Key: 92772fe7-8c86-4e3e-8315-11eaa04ff01e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Compact FM
• Version Model Number: 60130EXP
• 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	00815871020206 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150901

FDA Product Code

• HGM: System, Monitoring, Perinatal

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: 2020-03-02
• Device Publish Date: 2016-09-23

On-Brand Devices [Compact FM]

• 00815871020220: 60130TD
• 00815871020213: 60130T
• 00815871020206: 60130EXP
• 00815871020190: 60130