Catalog Number

-

Brand Name

EM 15 Blood Glucose Level 1 and Level 2 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

1274c6bb-f89d-4811-929f-92666153a504

Public Version Date

July 29, 2019

Public Version Number

1

DI Record Publish Date

July 19, 2019

Package DI Number

10885017000581

Quantity per Package

192

Contains DI Package

00885017000584

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton