Duns Number:658644174
Device Description: GL GoodLife Glucose Control Solution(Level 1) for use with GL GoodLife Blood Glucose Syste GL GoodLife Glucose Control Solution(Level 1) for use with GL GoodLife Blood Glucose System
Catalog Number
3C-01-810032
Brand Name
GL GoodLife Glucose Control Solution(Level 1)
Version/Model Number
GL GCS
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 28, 2018
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
K120064,K120064
Product Code
JJX
Product Code Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Public Device Record Key
dff656fb-df0c-4680-947c-bbec3b07d429
Public Version Date
December 28, 2018
Public Version Number
4
DI Record Publish Date
October 30, 2017
Package DI Number
00389154000716
Quantity per Package
650
Contains DI Package
00389154000440
Package Discontinue Date
December 28, 2018
Package Status
Not in Commercial Distribution
Package Type
box
| 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 |