Duns Number:658447255
Device Description: Easy Talk Blood Glucose Monitoring System(Meter Only Kit)
Catalog Number
-
Brand Name
Easy Talk
Version/Model Number
6277(BZG62277HAA)
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 02, 2016
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)
-
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
5baa7ca8-bf0a-4e9e-bf33-eecd31cdd4fe
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 02, 2016
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 | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |