Catalog Number

3K-01-16003R

Brand Name

GL GoodLife AC-302 Blood Glucose Monitoring System

Version/Model Number

AC-11 AC302

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 09, 2016

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

-

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

20373c2d-cba4-4269-aa21-d2f832395684

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 09, 2016

Package DI Number

00389154000648

Quantity per Package

60

Contains DI Package

00389154000631

Package Discontinue Date

December 09, 2016

Package Status

Not in Commercial Distribution

Package Type

-