Catalog Number

SMS002

Brand Name

Bard® DigniShield® Stool Management System

Version/Model Number

SMS002

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

0bc1dd83-5d6b-4fdb-962f-ea06ab98b0dd

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 25, 2016

Package DI Number

10801741045940

Quantity per Package

2

Contains DI Package

00801741045943

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA