Catalog Number

43437

Brand Name

NOVA MAX

Version/Model Number

GLU

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)

-

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

ebef02e3-3d8e-433b-9499-b06cffadff97

Public Version Date

March 06, 2019

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

20385480434373

Quantity per Package

1

Contains DI Package

10385480434376

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton