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Bard DigniShield Stool Management System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K102391

by C. R. Bard, Inc.

Identifiers

510(k) Number
K102391 FDA 510(k)
FDA Product Code
KNT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5980 FDA 510(k)
Regulation Number
876.5980 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESK Substantially Equivalent — Kit FDA 510(k)

The Bard DigniShield Stool Management System is a device intended for fecal management by diverting and collecting liquid or semi-liquid stool to minimize skin contact in bedridden patients and to provide access for the administration of medications. It is designed for adult use only and includes a catheter tube assembly, a collection bag, a 50mL syringe, a syringe of lubricating jelly, and a biological odor eliminator. The device has no components made of natural rubber latex.

The system is supplied as a single-use device and is not reusable. It is intended for use in a clinical setting and is regulated under FDA 510(k) clearance (K102391). Proper storage and handling should follow the manufacturer's instructions to ensure device integrity and functionality.

Frequently asked questions

What is the Bard DigniShield Stool Management System used for?

The Bard DigniShield Stool Management System is designed for fecal management in bedridden adult patients by diverting and collecting liquid or semi-liquid stool to minimize skin contact and provide access for medication administration.

What components are included in the Bard DigniShield system?

The system includes a catheter tube assembly, a collection bag, a 50mL syringe, a syringe of lubricating jelly, and a biological odor eliminator. It contains no components made of natural rubber latex.

Is the Bard DigniShield Stool Management System reusable?

No, the Bard DigniShield Stool Management System is supplied as a single-use device and is not intended for reuse. Proper storage and handling should follow the manufacturer's instructions to maintain device integrity and functionality.

What is the regulatory status of the Bard DigniShield system?

The Bard DigniShield Stool Management System is regulated under FDA 510(k) clearance with K number K102391. It is intended for use in clinical settings and has received clearance through the traditional review process.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: DigniShield™ Stool Management System - BD, MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD ..., DigniShield™ Stool Management System - SMS002 | BD, K102391 FDA 510(k) - BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
C. R. Bard, Inc.
FDA Applicant
C.R. Bard, Inc.

Sources (1)

  • FDA 510(k) K102391 24 fields · synced Sep 21, 2026