Catalog Number

125

Brand Name

NOVA

Version/Model Number

4/12

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K924743,K924743

Product Code

JFL

Product Code Name

PH RATE MEASUREMENT, CARBON-DIOXIDE

Public Device Record Key

dd160e8c-4d04-4d22-8211-5f72394e046c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

10385480001257

Quantity per Package

1

Contains DI Package

00385480001250

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton