AUVON

GUDID 16971292002519

The Self-adhesive electrode is intended to be used to transmit electrical stimulation current to the patient's skin. Example electrical stimulations for current applications of the electrodes are: TENS and EMS.

Shenzhen Yuwen E-Commerce Co., Ltd.

Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: 16971292002519
• NIH Device Record Key: f8503d5b-06c9-4574-80f2-bd7f2a8c0724
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AUVON
• Version Model Number: JJ5010
• Company DUNS: 544559614
• Company Name: Shenzhen Yuwen E-Commerce Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971292002512 [Primary]
GS1	16971292002519 [Package]; Contains: 06971292002512; Package: [540 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192568

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-26
• Device Publish Date: 2024-06-18

On-Brand Devices [AUVON]

• 16971292006258: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 06971292005513: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 06971292005506: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 16971292005251: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 16971292005237: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 16971292005213: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 06971292005100: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 06971292005087: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 06971292004417: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 06971292004028: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder,
• 26971292002929: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder,
• 16971292001239: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder,
• 16971292001215: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 16971292001154: The Draw-In blood glucose test strip is designed to provide an easy, accurate method for the det
• 16971292001123: The DS-W Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnost
• 16971292001093: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 06971292001041: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 69712920010450: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 06971292000419: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 06971292004431: The Adhesive Electrodes are intended for use as a reusable, conductive adhesive interface betwee
• 06971292001188: The Draw-In blood glucose test strip is designed to provide an easy, accurate method for the det
• 16971292001178: The DS-W Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnost
• 16971292002021: The Adhesive Electrodes are intended for use as a reusable, conductive adhesive interface betwee
• 16971292000324: To be used for the relief of pain associated with sore or aching muscles of the lower back, arms
• 16971292001246: The Draw-In blood glucose test strip is designed to provide an easy, accurate method for the det
• 16971292002083: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 16971292001277: The DS-W Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnost
• 16971292001291: The Draw-In blood glucose test strip is designed to provide an easy, accurate method for the det
• 16971292002106: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 16971292000478: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder,
• 16971292000430: TENS: To be used for temporary relief of pain associated with sore and aching muscles in the sh
• 16971292001376: The DS-W Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnost
• 16971292001352: The DS-W Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnost
• 16971292001338: The DS-W Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnost
• 16971292001314: The DS-W Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnost
• 16971292000485: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 16971292001390: The DS-W Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnost
• 16971292002113: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 16971292002120: The Adhesive Electrodes are intended for use as a reusable, conductive adhesive interface betwee
• 16971292000492: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 16971292001413: The DS-W Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnost
• 16971292001406: The DS-W Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnost
• 16971292000508: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 16971292002182: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 16971292002175: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 16971292002168: The Adhesive Electrodes are intended for use as a reusable, conductive adhesive interface betwee
• 06971292002154: The Adhesive Electrodes are intended for use as a reusable, conductive adhesive interface betwee
• 16971292001420: The DS-W Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnost
• 06971292002215: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 16971292002205: The Adhesive Electrodes are intended for use as a reusable, conductive adhesive interface betwee