Catalog Number

3S-01-16003E

Brand Name

GL GoodLife Blood Glucose Test Strip(CORP.)

Version/Model Number

AC-11 AC302 (vial)

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

Product Code

LFR

Product Code Name

Glucose Dehydrogenase, Glucose

Public Device Record Key

018f70f7-8c21-464d-aef8-d5d25a5830e2

Public Version Date

February 08, 2019

Public Version Number

1

DI Record Publish Date

January 08, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-