AUVON

GUDID 00860010656303

Changsha Anxiang Medical Technology Co., LTD

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 00860010656303
• NIH Device Record Key: 1d717cb6-e6bf-4929-bca5-1b1b1c1f5e80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AUVON
• Version Model Number: TU3416
• Company DUNS: 713356300
• Company Name: Changsha Anxiang Medical Technology Co., LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010656303 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212184

FDA Product Code

• NUH: Stimulator, Nerve, Transcutaneous, Over-The-Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-30
• Device Publish Date: 2023-10-21

On-Brand Devices [AUVON]

• 00860010656334: TU3336
• 00860010656327: TU3236
• 00860010656310: TU1130
• 00860010656303: TU3416