Duns Number:658644174
Device Description: The GoodLife AC-300 Professional Blood Glucose Monitoring System.(No NFC)
Catalog Number
3K-01-16003G
Brand Name
GL GoodLife
Version/Model Number
AC11-NFC
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"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
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
ed8bc5ec-7242-4915-89db-1bc12eb0f04b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 01, 2016
Package DI Number
04711200722154
Quantity per Package
63
Contains DI Package
04711200721850
Package Discontinue Date
-
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 |