Compact II

GUDID 00815871020299

Avante

Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor

• Primary Device ID: 00815871020299
• NIH Device Record Key: 3978c61f-6ccf-4360-87e2-96c848c14e68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Compact II
• Version Model Number: 60132II
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815871020299 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102140

FDA Product Code

• HGL: Transducer, Ultrasonic, Obstetric

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: 2019-06-19
• Device Publish Date: 2016-09-23

Devices Manufactured by Avante

• 00815871020091 - Disposable Monopolar Handswitching Pencil: 2020-03-02
• 00815871020190 - Compact FM: 2020-03-02
• 00815871020206 - Compact FM: 2020-03-02
• 00815871020213 - Compact FM: 2020-03-02
• 00815871020220 - Compact FM: 2020-03-02
• 00815871020237 - Compact Plus: 2020-03-02
• 00815871020244 - Compact Plus: 2020-03-02
• 00815871020251 - Compact Plus: 2020-03-02