Catalog Number

ENSMS002

Brand Name

Bard® DigniShield® Stool Management System with ENFit™

Version/Model Number

ENSMS002

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

KNT

Product Code Name

TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Public Device Record Key

3a806536-d488-4087-87b8-09b88789268e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 03, 2016

Package DI Number

10801741113144

Quantity per Package

2

Contains DI Package

00801741113147

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA