Catalog Number

-

Brand Name

Embrace Pro Blood Glucose Test Strip

Version/Model Number

AGM-4000

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)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K083628,K083628,K083628

Product Code

JJX

Product Code Name

Single (Specified) Analyte Controls (Assayed And Unassayed)

Public Device Record Key

2d0359b5-d7e4-4ca6-83d0-6f7cb5130329

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 23, 2016

Package DI Number

08806128340026

Quantity per Package

2

Contains DI Package

08806128340019

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-