Sage 12c

GUDID 00815871021425

Avante

Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder Electrocardiographic ambulatory recorder

• Primary Device ID: 00815871021425
• NIH Device Record Key: 6064767d-f21d-428e-9add-a3926aad0bd9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sage 12c
• Version Model Number: 60130H
• 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	00815871021425 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151787

FDA Product Code

• MWJ: Electrocardiograph,Ambulatory(Without Analysis)

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: 2019-11-08
• 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