Duns Number:690184887
Catalog Number
-
Brand Name
GlucoTrack Voice Blood Glucose Monitoring System
Version/Model Number
GT-301
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
K113636
Product Code
CGA
Product Code Name
Glucose Oxidase, Glucose
Public Device Record Key
a983aa95-442e-42c8-a6dc-bc66eab30090
Public Version Date
September 17, 2018
Public Version Number
1
DI Record Publish Date
August 16, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 9 |
2 | A medical device with a moderate to high risk that requires special controls. | 23 |