Waveline Touch+

GUDID 00815871021203

Avante

Patient monitoring system module, blood gas, transcutaneous

• Primary Device ID: 00815871021203
• NIH Device Record Key: 65d81d67-c7b4-4298-8083-842302ee9a2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Waveline Touch+
• Version Model Number: 60145TNTSRS
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815871021203 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131971

FDA Product Code

• DSI: Detector And Alarm, Arrhythmia

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: 2020-02-06
• Device Publish Date: 2016-09-23

On-Brand Devices [Waveline Touch+]

• 00815871021210: 60145TP
• 00815871021203: 60145TNTSRS
• 00815871021197: 60145TCO2S
• 00815871021180: 60145T