Catalog Number

-

Brand Name

Easy Plus II

Version/Model Number

GOD31(BZL001HAB)

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 02, 2016

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

f60a344e-9d48-41c4-8da9-ca041889e788

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 02, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-