Catalog Number

-

Brand Name

EM 15 Blood Glucose Level 1 Control Solution

Version/Model Number

EM44

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"

Yes

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

-

Product Code

NBW

Product Code Name

System, Test, Blood Glucose, Over The Counter

Public Device Record Key

a77b84f5-e674-496d-82a0-6a071f6bed3b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 12, 2016

Package DI Number

01885017000361

Quantity per Package

12

Contains DI Package

00885017000362

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton