Catalog Number

18342

Brand Name

NOVA

Version/Model Number

16

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K963005

Product Code

CDS

Product Code Name

ELECTRODE, ION SPECIFIC, UREA NITROGEN

Public Device Record Key

6509ef01-bcc2-41e0-8df3-c0ee007a59d8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 24, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-