Catalog Number

3K-01-16003R

Brand Name

GL GoodLife AC-302 Blood Glucose Monitoring System(CORP.)

Version/Model Number

AC-11 AC302

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

-

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

86ac89bc-2150-4202-8b8d-6d96f4227671

Public Version Date

February 08, 2019

Public Version Number

1

DI Record Publish Date

January 08, 2019

Package DI Number

00857596008039

Quantity per Package

60

Contains DI Package

00857596008022

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-