Catalog Number

15742

Brand Name

NOVA

Version/Model Number

4/10/11/13

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

K915176,K915176

Product Code

NDW

Product Code Name

Assay, porphyrin, spectrophotometry, lithium

Public Device Record Key

134b5c1d-89d1-42a5-a60b-f2357bc7d901

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

10385480157428

Quantity per Package

3

Contains DI Package

00385480157421

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton