Waveline Nano B2

GUDID 00815871021067

Avante

Pulse oximeter, battery-powered

• Primary Device ID: 00815871021067
• NIH Device Record Key: 87f2fe1f-f7c8-4cda-b8eb-1309ed35b839
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Waveline Nano B2
• Version Model Number: 60139
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815871021067 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092727

FDA Product Code

• DQA: Oximeter

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

On-Brand Devices [Waveline Nano B2]

• 00815871021074: 60147B2
• 00815871021067: 60139