Duns Number:080339637
Device Description: Blood Glucose Test Strips (50 count)
Catalog Number
-
Brand Name
D-Care
Version/Model Number
50003A
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K132086,K132086,K132086
Product Code
CGA
Product Code Name
Glucose Oxidase, Glucose
Public Device Record Key
b93e5ed2-0a03-4fa5-b083-cfbaadec1f55
Public Version Date
September 09, 2020
Public Version Number
4
DI Record Publish Date
July 24, 2017
Package DI Number
20370914003058
Quantity per Package
216
Contains DI Package
00370914003054
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case Box