Catalog Number

53493

Brand Name

NOVA

Version/Model Number

MAX PLUS KETONE

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

JIN

Product Code Name

NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)

Public Device Record Key

5d6eb5a9-67da-4df4-bf77-e71a81fa9157

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 20, 2016

Package DI Number

20385480534936

Quantity per Package

2

Contains DI Package

10385480534939

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton