Catalog Number

-

Brand Name

EasyMax 15 NHCS Set EN

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

27a98b59-2f1b-4233-8cb3-e00a5657f76e

Public Version Date

July 01, 2020

Public Version Number

1

DI Record Publish Date

June 23, 2020

Package DI Number

10885017000567

Quantity per Package

192

Contains DI Package

00885017000560

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton