Catalog Number

PNVMESCHH

Brand Name

CARDINAL HEALTH

Version/Model Number

PNVMESCHH

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"

Yes

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

-

Product Code

NWU

Product Code Name

Kit, introducer, endoscope

Public Device Record Key

f64b88c3-20ed-4544-831f-f0691354c5f8

Public Version Date

July 17, 2018

Public Version Number

3

DI Record Publish Date

September 25, 2015

Package DI Number

50887488033912

Quantity per Package

1

Contains DI Package

00887488033917

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE