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Bard® DigniShield® Stool Management System Collection Bags

FDA UDI

Class II (US FDA UDI)

by C. R. Bard, Inc.

Identity

Trade Name
Bard® DigniShield® Stool Management System Collection Bags FDA UDI
Generic Name
Faecal incontinence collector, catheterization FDA UDI
Device Name
Bard® DigniShield® Stool Management System Collection Bags FDA UDI
Model / Reference
SMS2B1L FDA UDI
Description
Bard® DigniShield® Stool Management System Collection Bags FDA UDI

Identifiers

Catalog Number
SMS2B1L FDA UDI
Primary DI / UDI-DI
00801741045967 FDA UDI
FDA Product Code
KNT FDA UDI
GMDN Term
Faecal incontinence collector, catheterization FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5980 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Faecal incontinence collector, catheterization

Bard® DigniShield® Stool Management System Collection Bags by C. R. Bard, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Faecal incontinence collector, catheterization.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
C. R. Bard, Inc.

Sources (1)

  • FDA UDI e0748ee8-acdc-48e8-9dea-e9d61c0e04b4 35 fields · synced May 30, 2026