Duns Number:658644174
Device Description: GL GoodLife Blood Glucose Monitoring System(Cloudia)
Catalog Number
3K-01-810037
Brand Name
GL GoodLife
Version/Model Number
IG01
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 13, 2017
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"
Yes
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
K131173,K131173
Product Code
JJX
Product Code Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Public Device Record Key
1c87ebd1-d478-4e0a-9d57-70736ceb00c2
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 07, 2016
Package DI Number
00389154000471
Quantity per Package
60
Contains DI Package
00389154000372
Package Discontinue Date
March 13, 2017
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 |