AUVON

GUDID 16971292001246

The Draw-In blood glucose test strip is designed to provide an easy, accurate method for the determination of capillary whole blood glucose values. This analysis employs the enzyme glucose oxidase and is based on advanced biosensor technology that is specific for -D-glucose measurement. The test strips are designed in such a way that when the blood is applied to the edge of reaction zone, the glucose oxidase triggers the oxidation of glucose in the blood. The intensity of the electrons formed is measured by the meter and correlates well with the concentration of glucose in the blood sample.

Shenzhen Yuwen E-Commerce Co., Ltd.

Glucose IVD, kit, enzyme spectrophotometry, rapid

• Primary Device ID: 16971292001246
• NIH Device Record Key: 413bb3c9-8e5b-4f00-a7dc-26daf511cb6a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AUVON
• Version Model Number: TS1150011
• Company DUNS: 544559614
• Company Name: Shenzhen Yuwen E-Commerce Co., Ltd.
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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	06971292001218 [Unit of Use]
GS1	06971292001256 [Primary]
GS1	16971292001246 [Package]; Contains: 06971292001256; Package: carton box [150 Units]; In Commercial Distribution

FDA Product Code

• FMK: Lancet, Blood

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: 2019-09-18
• Device Publish Date: 2019-09-10

On-Brand Devices [AUVON]

• 16971292005251: 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
• 16971292006258: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 16971292001093: 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
• 06971292004417: 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
• 06971292005506: 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
• 06971292005513: 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
• 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
• 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
• 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
• 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
• 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
• 16971292000324: To be used for the relief of pain associated with sore or aching muscles of the lower back, arms
• 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