Duns Number:658644174
Device Description: Only GL GoodLife Blood Glucose Meter. No GCS in package, Economy type
Catalog Number
3K-01-16003N
Brand Name
GL GoodLife Blood Glucose Monitoring System
Version/Model Number
AC-11 AC302
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 09, 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
K113307,K113307
Product Code
LFR
Product Code Name
Glucose Dehydrogenase, Glucose
Public Device Record Key
8da337b4-92e9-47fd-b2da-0943d3f7104d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 09, 2016
Package DI Number
00389154000624
Quantity per Package
60
Contains DI Package
00389154000617
Package Discontinue Date
December 09, 2016
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |