Duns Number:658644174
Device Description: GL GoodLife AC-300 Blood Glucose Monitoring System
Catalog Number
3K-01-16003C
Brand Name
GL GoodLife
Version/Model Number
AC11
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K140150,K140150
Product Code
LFR
Product Code Name
Glucose Dehydrogenase, Glucose
Public Device Record Key
ff15bbdf-cfaf-4b2a-9286-5165646c1fd2
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 17, 2016
Package DI Number
00389154000655
Quantity per Package
63
Contains DI Package
00389154000198
Package Discontinue Date
-
Package Status
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 |