AUVON

GUDID 16971292007019

The DS-W Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The DS-W Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The DS-W Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The DS-W Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). The DS-W Draw-in Blood Glucose Test Strips are for use with the DS-W Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

Shenzhen Yuwen E-Commerce Co., Ltd.

Glucose monitoring system IVD, home-use

• Primary Device ID: 16971292007019
• NIH Device Record Key: dfcda441-650b-48ee-9668-d52e817e24d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AUVON
• Version Model Number: DS-W
• 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: 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: true

Customer Support Contacts

• Phone: +1(678)829-7256
• Email: support@iauvon.com
• Phone: +1(678)829-7256
• Email: support@iauvon.com
• Phone: +1(678)829-7256
• Email: support@iauvon.com
• Phone: +1(678)829-7256
• Email: support@iauvon.com
• Phone: +1(678)829-7256
• Email: support@iauvon.com
• Phone: +1(678)829-7256
• Email: support@iauvon.com
• Phone: +1(678)829-7256
• Email: support@iauvon.com
• Phone: +1(678)829-7256
• Email: support@iauvon.com
• Phone: +1(678)829-7256
• Email: support@iauvon.com
• Phone: +1(678)829-7256
• Email: support@iauvon.com
• Phone: +1(678)829-7256
• Email: support@iauvon.com
• Phone: +1(678)829-7256
• Email: support@iauvon.com
• Phone: +1(678)829-7256
• Email: support@iauvon.com
• Phone: +1(678)829-7256
• Email: support@iauvon.com
• Phone: +1(678)829-7256
• Email: support@iauvon.com
• Phone: +1(678)829-7256
• Email: support@iauvon.com
• Phone: +1(678)829-7256
• Email: support@iauvon.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971292007012 [Primary]
GS1	16971292007019 [Package]; Contains: 06971292007012; Package: [80 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132663

FDA Product Code

• CGA: Glucose Oxidase, Glucose

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: 2024-08-22
• Device Publish Date: 2024-08-14

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