Catalog Number

-

Brand Name

GLUCOCARD® EXPRESSION Blood Glucose Monitoring System

Version/Model Number

571100

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K113098,K113098,K113098

Product Code

NBW

Product Code Name

SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Public Device Record Key

b0f94688-5a3a-4145-a0d5-6ce37a34b362

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

10015482571105

Quantity per Package

4

Contains DI Package

00015482571108

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Pack