Duns Number:080339637
Device Description: DM2- kit contains one 60ct. bottle of Metformin 500mg and one 50ct. bottle Test Strips
Catalog Number
-
Brand Name
D-Care
Version/Model Number
50002A
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
242eea32-ccb8-4722-bc43-2e3c3d7461d6
Public Version Date
September 09, 2020
Public Version Number
9
DI Record Publish Date
July 24, 2017
Package DI Number
10370914006014
Quantity per Package
10
Contains DI Package
00370914006017
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper box