Duns Number:658644174
Device Description: GL GoodLife Blood Glucose Test Strip(Content:50 strips and 50 lancet.)
Catalog Number
3L-10-16003F
Brand Name
GL GoodLife AC11-Strip(foil)
Version/Model Number
3L-10-16003F
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
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
K113307,K113307
Product Code
JJX
Product Code Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Public Device Record Key
264a4d39-50c6-4b86-bc91-c6e4d92461d6
Public Version Date
August 20, 2018
Public Version Number
4
DI Record Publish Date
January 25, 2017
Package DI Number
00389154000709
Quantity per Package
120
Contains DI Package
00389154000693
Package Discontinue Date
January 25, 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 |