Catalog Number

43436

Brand Name

Nova Max

Version/Model Number

Plus

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

-

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

422cd2a3-959b-450d-bdc6-061d6fca161e

Public Version Date

March 06, 2019

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

10385480434369

Quantity per Package

1

Contains DI Package

00385480434362

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton