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.
Catalog Number
-
Brand Name
AUVON
Version/Model Number
DS-W10025011
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
CGA
Product Code Name
Glucose Oxidase, Glucose
Public Device Record Key
52ebf344-3159-4c34-acbc-5b41bae8648b
Public Version Date
November 04, 2019
Public Version Number
1
DI Record Publish Date
October 25, 2019
Package DI Number
16971292001314
Quantity per Package
100
Contains DI Package
06971292001300
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 99 |