AUVON - The DS-W Blood Glucose Monitoring System is - Shenzhen Yuwen E-Commerce Co., Ltd.

Duns Number:544559614

Device Description: The DS-W Blood Glucose Monitoring System is intended for use outside the body (in vitro di The DS-W Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use). It should be used only for testing purposes and only with fresh whole blood samples. It should not be used for the diagnosis of diabetes.

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More Product Details

Catalog Number

-

Brand Name

AUVON

Version/Model Number

DS-W1001002

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Device Record Status

Public Device Record Key

6175c76e-c8cb-4b4e-a3a2-1457e1351807

Public Version Date

December 05, 2019

Public Version Number

1

DI Record Publish Date

November 27, 2019

Additional Identifiers

Package DI Number

16971292001390

Quantity per Package

85

Contains DI Package

06971292001393

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton box

"SHENZHEN YUWEN E-COMMERCE CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 99