AUVON

GUDID 06971292006985

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 ID06971292006985
NIH Device Record Keyec2bf491-75dc-416c-9d04-a5a24f1ff0ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameAUVON
Version Model NumberDS-W
Company DUNS544559614
Company NameShenzhen Yuwen E-Commerce Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(678)829-7256
Emailsupport@iauvon.com
Phone+1(678)829-7256
Emailsupport@iauvon.com
Phone+1(678)829-7256
Emailsupport@iauvon.com
Phone+1(678)829-7256
Emailsupport@iauvon.com
Phone+1(678)829-7256
Emailsupport@iauvon.com
Phone+1(678)829-7256
Emailsupport@iauvon.com
Phone+1(678)829-7256
Emailsupport@iauvon.com
Phone+1(678)829-7256
Emailsupport@iauvon.com
Phone+1(678)829-7256
Emailsupport@iauvon.com
Phone+1(678)829-7256
Emailsupport@iauvon.com
Phone+1(678)829-7256
Emailsupport@iauvon.com
Phone+1(678)829-7256
Emailsupport@iauvon.com
Phone+1(678)829-7256
Emailsupport@iauvon.com
Phone+1(678)829-7256
Emailsupport@iauvon.com
Phone+1(678)829-7256
Emailsupport@iauvon.com
Phone+1(678)829-7256
Emailsupport@iauvon.com
Phone+1(678)829-7256
Emailsupport@iauvon.com

Device Identifiers

Device Issuing AgencyDevice ID
GS106971292006985 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CGAGlucose Oxidase, Glucose

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-22
Device Publish Date2024-08-14

On-Brand Devices [AUVON]

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

Trademark Results [AUVON]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AUVON
AUVON
98720718 not registered Live/Pending
Shenzhen Yuwen E-Commerce Co., Ltd.
2024-08-28
AUVON
AUVON
98579288 not registered Live/Pending
Shenzhen Yuwen E-Commerce Co., Ltd.
2024-05-31
AUVON
AUVON
98579194 not registered Live/Pending
Shenzhen Yuwen E-Commerce Co., Ltd.
2024-05-31
AUVON
AUVON
98566372 not registered Live/Pending
Shenzhen Yuwen E-Commerce Co., Ltd.
2024-05-23
AUVON
AUVON
98566157 not registered Live/Pending
Shenzhen Yuwen E-Commerce Co., Ltd.
2024-05-23
AUVON
AUVON
97928796 not registered Live/Pending
Shenzhen Yuwen E-Commerce Co.,Ltd.
2023-05-10
AUVON
AUVON
97635651 not registered Live/Pending
Shenzhen Yuwen E-Commerce Co., Ltd.
2022-10-17
AUVON
AUVON
97628023 not registered Live/Pending
Shenzhen Yuwen E-Commerce Co.,Ltd.
2022-10-11
AUVON
AUVON
97628011 not registered Live/Pending
Shenzhen Yuwen E-Commerce Co.,Ltd.
2022-10-11
AUVON
AUVON
88671971 not registered Live/Pending
Shenzhen Yuwen E-Commerce Co., Ltd.
2019-10-29
AUVON
AUVON
88660227 not registered Live/Pending
Shenzhen Yuwen E-Commerce Co., Ltd.
2019-10-18
AUVON
AUVON
88509041 not registered Live/Pending
Shenzhen Yuwen E-Commerce Co.,Ltd.
2019-07-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.